Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-01-17 @ 2:53 AM
Study NCT ID:
NCT03834168
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2019-02-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Diurnal Rhythm in Natriuretic Peptide Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'parora@uabmc.edu', 'phone': '2059754720', 'title': 'Dr. Pankaj Arora', 'organization': 'UNIVERSITY OF ALABAMA AT BIRMINGHAM'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 month', 'eventGroups': [{'id': 'EG000', 'title': 'Lean', 'description': 'Healthy self-identified African-American and white lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).\n\nstandardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Obese', 'description': 'Healthy self-identified African-American and white obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).\n\nstandardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plasma MRproANP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean', 'description': 'Healthy self-identified African-American and white lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).\n\nstandardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Healthy self-identified African-American and white obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).\n\nstandardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.92', 'groupId': 'OG000', 'lowerLimit': '12.94', 'upperLimit': '25.21'}, {'value': '15.51', 'groupId': 'OG001', 'lowerLimit': '10.61', 'upperLimit': '22.02'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000'], 'statisticalMethod': 'Regression (Cosinor Fit)', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'About 24 hours on the in-patient study visit day after consuming study meals for 5 days', 'description': 'Assess the diurnal rhythm in circulating MRproANP levels among obese individuals and compared it with lean individuals', 'unitOfMeasure': 'pmol/l', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acrophase Difference in Hours Between the MR-proANP and Systolic BP Rhythm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean', 'description': 'Healthy self-identified African-American and white lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).\n\nstandardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Healthy self-identified African-American and white obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).\n\nstandardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'About 24 hours on the in-patient study visit day after consuming study meals for 5 days', 'description': 'Assess relationship between 24-hour variability of MRproANP levels and 24-hour patterns of blood pressure and whether this relationship of rhythmicity of MRproANP levels and nocturnal blood pressure differed in obese and lean individuals and by race', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Plasma MRproANP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean', 'description': 'Healthy self-identified African-American and white male lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).\n\nstandardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Healthy self-identified African-American and white male obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).\n\nstandardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.'}], 'timeFrame': 'About 24 hours on the in-patient study visit day after consuming study meals for 5 days', 'description': 'Assess the diurnal rhythm in circulating MRproANP levels among African-American individuals and compared it with white individuals', 'reportingStatus': 'POSTED', 'populationDescription': 'The race-specific analysis was not done for this study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lean', 'description': 'Healthy self-identified African-American and white male lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).\n\nstandardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.'}, {'id': 'FG001', 'title': 'Obese', 'description': 'Healthy self-identified African-American and white male obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).\n\nstandardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': '42 participants started the study; 19 Lean and 23 Obese', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Total Participant Screened for the Purpose of Eligibility', 'comment': '52 Participants were screened for the eligibilty', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Ineligible Participants', 'comment': '10 participants determined ineligible by screening labs', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Unable to Complete the Protocol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study Dropouts', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participants Received 5 Days of Standardized Meals', 'comment': '42 participants received 5 days of standardized meals to control the salt intake', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Participants Returned for the 24-h Inpatient Protocol', 'comment': '41 participants returned for the 24-h inpatient protocol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'comment': '40 participants completed the study; 18 Lean and 22 Obese', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 42 participants agreed to participate in the study following the completion of the informed consent process and were assigned to each Arm/group. We had one study dropout and one participant was not able to complete the protocol. A total of 40 participants completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lean', 'description': 'Healthy self-identified African-American and white lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).\n\nstandardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.'}, {'id': 'BG001', 'title': 'Obese', 'description': 'Healthy self-identified African-American and white obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).\n\nstandardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'groupId': 'BG000', 'lowerLimit': '24.0', 'upperLimit': '32.0'}, {'value': '33.0', 'groupId': 'BG001', 'lowerLimit': '26.0', 'upperLimit': '37.0'}, {'value': '31.0', 'groupId': 'BG002', 'lowerLimit': '26.0', 'upperLimit': '35.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'groupId': 'BG000', 'lowerLimit': '21.9', 'upperLimit': '25.0'}, {'value': '32.2', 'groupId': 'BG001', 'lowerLimit': '30.7', 'upperLimit': '36.0'}, {'value': '29.6', 'groupId': 'BG002', 'lowerLimit': '24.4', 'upperLimit': '32.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Hip circumference', 'classes': [{'categories': [{'measurements': [{'value': '97.3', 'groupId': 'BG000', 'lowerLimit': '93.8', 'upperLimit': '101.0'}, {'value': '111.4', 'groupId': 'BG001', 'lowerLimit': '106.1', 'upperLimit': '118.7'}, {'value': '106.1', 'groupId': 'BG002', 'lowerLimit': '96.1', 'upperLimit': '114.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Waist circumference', 'classes': [{'categories': [{'measurements': [{'value': '76.9', 'groupId': 'BG000', 'lowerLimit': '73.5', 'upperLimit': '85.7'}, {'value': '103.6', 'groupId': 'BG001', 'lowerLimit': '99.8', 'upperLimit': '111.8'}, {'value': '97.6', 'groupId': 'BG002', 'lowerLimit': '78.3', 'upperLimit': '105.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '110.7', 'groupId': 'BG000', 'lowerLimit': '102.0', 'upperLimit': '122.7'}, {'value': '116.5', 'groupId': 'BG001', 'lowerLimit': '108.3', 'upperLimit': '126.0'}, {'value': '116.2', 'groupId': 'BG002', 'lowerLimit': '106.0', 'upperLimit': '123.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Diastolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '69.5', 'groupId': 'BG000', 'lowerLimit': '64.3', 'upperLimit': '76.0'}, {'value': '73.7', 'groupId': 'BG001', 'lowerLimit': '67.7', 'upperLimit': '80.0'}, {'value': '71.0', 'groupId': 'BG002', 'lowerLimit': '65.3', 'upperLimit': '78.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Heart rate', 'classes': [{'categories': [{'measurements': [{'value': '76.5', 'groupId': 'BG000', 'lowerLimit': '66.0', 'upperLimit': '80.0'}, {'value': '77.0', 'groupId': 'BG001', 'lowerLimit': '71.0', 'upperLimit': '80.0'}, {'value': '77.0', 'groupId': 'BG002', 'lowerLimit': '69.0', 'upperLimit': '80.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'beats/min', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Fasting Glucose', 'classes': [{'categories': [{'measurements': [{'value': '85.0', 'groupId': 'BG000', 'lowerLimit': '79.0', 'upperLimit': '96.0'}, {'value': '91.5', 'groupId': 'BG001', 'lowerLimit': '82.0', 'upperLimit': '100.0'}, {'value': '87.5', 'groupId': 'BG002', 'lowerLimit': '81.0', 'upperLimit': '97.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Renal Function', 'classes': [{'title': 'Blood Urea Nitrogen (BUN)', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'BG000', 'lowerLimit': '11.0', 'upperLimit': '13.0'}, {'value': '12.0', 'groupId': 'BG001', 'lowerLimit': '10.0', 'upperLimit': '14.0'}, {'value': '12', 'groupId': 'BG002', 'lowerLimit': '10.5', 'upperLimit': '14.0'}]}]}, {'title': 'Serum Creatinine', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'BG000', 'lowerLimit': '0.8', 'upperLimit': '0.9'}, {'value': '0.9', 'groupId': 'BG001', 'lowerLimit': '0.8', 'upperLimit': '1.0'}, {'value': '0.9', 'groupId': 'BG002', 'lowerLimit': '0.8', 'upperLimit': '0.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Serum Electrolytes', 'classes': [{'title': 'Sodium, mEq/L', 'categories': [{'measurements': [{'value': '137.5', 'groupId': 'BG000', 'lowerLimit': '137.0', 'upperLimit': '139.0'}, {'value': '138.0', 'groupId': 'BG001', 'lowerLimit': '136.0', 'upperLimit': '138.0'}, {'value': '138.0', 'groupId': 'BG002', 'lowerLimit': '136.5', 'upperLimit': '138.5'}]}]}, {'title': 'Potassium, mEq/L', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'BG000', 'lowerLimit': '3.9', 'upperLimit': '4.3'}, {'value': '4.2', 'groupId': 'BG001', 'lowerLimit': '4.0', 'upperLimit': '4.3'}, {'value': '4.2', 'groupId': 'BG002', 'lowerLimit': '3.9', 'upperLimit': '4.3'}]}]}, {'title': 'Chloride, mEq/L', 'categories': [{'measurements': [{'value': '102.5', 'groupId': 'BG000', 'lowerLimit': '102.0', 'upperLimit': '104.0'}, {'value': '103.5', 'groupId': 'BG001', 'lowerLimit': '102.0', 'upperLimit': '105.0'}, {'value': '103.0', 'groupId': 'BG002', 'lowerLimit': '102.0', 'upperLimit': '104.0'}]}]}, {'title': 'Bicarbonate, mEq/L', 'categories': [{'measurements': [{'value': '26.0', 'groupId': 'BG000', 'lowerLimit': '25.0', 'upperLimit': '28.0'}, {'value': '26.0', 'groupId': 'BG001', 'lowerLimit': '25.0', 'upperLimit': '27.0'}, {'value': '26.0', 'groupId': 'BG002', 'lowerLimit': '25.0', 'upperLimit': '27.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Serum Calcium', 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'groupId': 'BG000', 'lowerLimit': '9.3', 'upperLimit': '9.7'}, {'value': '9.6', 'groupId': 'BG001', 'lowerLimit': '9.2', 'upperLimit': '9.8'}, {'value': '9.6', 'groupId': 'BG002', 'lowerLimit': '9.3', 'upperLimit': '9.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Liver Function', 'classes': [{'title': 'Total bilirubin', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'BG000', 'lowerLimit': '0.4', 'upperLimit': '0.8'}, {'value': '0.5', 'groupId': 'BG001', 'lowerLimit': '0.4', 'upperLimit': '0.7'}, {'value': '0.5', 'groupId': 'BG002', 'lowerLimit': '0.4', 'upperLimit': '0.8'}]}]}, {'title': 'Alanine transaminase (ALT)', 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'BG000', 'lowerLimit': '11.0', 'upperLimit': '16.0'}, {'value': '17.0', 'groupId': 'BG001', 'lowerLimit': '12.0', 'upperLimit': '27.0'}, {'value': '14.0', 'groupId': 'BG002', 'lowerLimit': '12.0', 'upperLimit': '20.0'}]}]}, {'title': 'Aspartate transaminase (AST)', 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'BG000', 'lowerLimit': '14.0', 'upperLimit': '20.0'}, {'value': '17.0', 'groupId': 'BG001', 'lowerLimit': '14.0', 'upperLimit': '23.0'}, {'value': '17.0', 'groupId': 'BG002', 'lowerLimit': '14.0', 'upperLimit': '20.0'}]}]}, {'title': 'Gamma-glutamyl transferase (GGT)', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'BG000', 'lowerLimit': '12.0', 'upperLimit': '24.0'}, {'value': '22.5', 'groupId': 'BG001', 'lowerLimit': '15.0', 'upperLimit': '27.0'}, {'value': '20.0', 'groupId': 'BG002', 'lowerLimit': '12.5', 'upperLimit': '25.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Hematological Parameters', 'classes': [{'title': 'WBC, * 10,000/mm3', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'BG000', 'lowerLimit': '4.3', 'upperLimit': '6.7'}, {'value': '5.5', 'groupId': 'BG001', 'lowerLimit': '4.6', 'upperLimit': '6.1'}, {'value': '5.4', 'groupId': 'BG002', 'lowerLimit': '4.4', 'upperLimit': '6.3'}]}]}, {'title': 'RBC, * 1,000,000/mm3', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'BG000', 'lowerLimit': '4.1', 'upperLimit': '5.0'}, {'value': '4.7', 'groupId': 'BG001', 'lowerLimit': '4.1', 'upperLimit': '5.0'}, {'value': '4.7', 'groupId': 'BG002', 'lowerLimit': '4.1', 'upperLimit': '5.0'}]}]}, {'title': 'Platelet, * 100,000/mm3', 'categories': [{'measurements': [{'value': '217.7', 'groupId': 'BG000', 'lowerLimit': '192.8', 'upperLimit': '274.9'}, {'value': '248.7', 'groupId': 'BG001', 'lowerLimit': '223.6', 'upperLimit': '268.2'}, {'value': '243.4', 'groupId': 'BG002', 'lowerLimit': '202.2', 'upperLimit': '271.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells*10,000/mm^3', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Hemoglobin', 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'groupId': 'BG000', 'lowerLimit': '13.1', 'upperLimit': '14.9'}, {'value': '14.2', 'groupId': 'BG001', 'lowerLimit': '13.2', 'upperLimit': '14.8'}, {'value': '14.2', 'groupId': 'BG002', 'lowerLimit': '13.2', 'upperLimit': '14.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Hematocrit', 'classes': [{'categories': [{'measurements': [{'value': '40.5', 'groupId': 'BG000', 'lowerLimit': '37.0', 'upperLimit': '43.0'}, {'value': '41.0', 'groupId': 'BG001', 'lowerLimit': '38.0', 'upperLimit': '43.0'}, {'value': '41.0', 'groupId': 'BG002', 'lowerLimit': '37.5', 'upperLimit': '43.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': '%', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Mean Corpuscular Volume (MCV)', 'classes': [{'categories': [{'measurements': [{'value': '87.5', 'groupId': 'BG000', 'lowerLimit': '84.0', 'upperLimit': '90.0'}, {'value': '89.0', 'groupId': 'BG001', 'lowerLimit': '86.0', 'upperLimit': '92.0'}, {'value': '88.0', 'groupId': 'BG002', 'lowerLimit': '86.0', 'upperLimit': '91.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'fl', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Mean Corpuscular Hemoglobin (MCH)', 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'groupId': 'BG000', 'lowerLimit': '29.0', 'upperLimit': '31.0'}, {'value': '31.0', 'groupId': 'BG001', 'lowerLimit': '29.0', 'upperLimit': '32.0'}, {'value': '30.0', 'groupId': 'BG002', 'lowerLimit': '29.0', 'upperLimit': '31.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Mean Corpuscular Hemoglobin Concentration (MCHC)', 'classes': [{'categories': [{'measurements': [{'value': '34.0', 'groupId': 'BG000', 'lowerLimit': '33.0', 'upperLimit': '34.0'}, {'value': '34.0', 'groupId': 'BG001', 'lowerLimit': '33.0', 'upperLimit': '35.0'}, {'value': '34.0', 'groupId': 'BG002', 'lowerLimit': '33.0', 'upperLimit': '34.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Red Cell Distribution Width (RDW)', 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'groupId': 'BG000', 'lowerLimit': '13.1', 'upperLimit': '13.9'}, {'value': '13.3', 'groupId': 'BG001', 'lowerLimit': '12.8', 'upperLimit': '14.5'}, {'value': '13.5', 'groupId': 'BG002', 'lowerLimit': '12.8', 'upperLimit': '14.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': '%', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Mean Platelet Volume (MPV)', 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'groupId': 'BG000', 'lowerLimit': '8.0', 'upperLimit': '9.0'}, {'value': '8.0', 'groupId': 'BG001', 'lowerLimit': '8.0', 'upperLimit': '9.0'}, {'value': '9.0', 'groupId': 'BG002', 'lowerLimit': '8.0', 'upperLimit': '9.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'fL', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-20', 'size': 192900, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-28T18:42', 'hasProtocol': True}, {'date': '2021-01-20', 'size': 205794, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-05-28T18:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2019-02-06', 'resultsFirstSubmitDate': '2021-05-28', 'studyFirstSubmitQcDate': '2019-02-06', 'lastUpdatePostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-30', 'studyFirstPostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Plasma MRproANP', 'timeFrame': 'About 24 hours on the in-patient study visit day after consuming study meals for 5 days', 'description': 'Assess the diurnal rhythm in circulating MRproANP levels among African-American individuals and compared it with white individuals'}], 'primaryOutcomes': [{'measure': 'Plasma MRproANP', 'timeFrame': 'About 24 hours on the in-patient study visit day after consuming study meals for 5 days', 'description': 'Assess the diurnal rhythm in circulating MRproANP levels among obese individuals and compared it with lean individuals'}], 'secondaryOutcomes': [{'measure': 'Acrophase Difference in Hours Between the MR-proANP and Systolic BP Rhythm', 'timeFrame': 'About 24 hours on the in-patient study visit day after consuming study meals for 5 days', 'description': 'Assess relationship between 24-hour variability of MRproANP levels and 24-hour patterns of blood pressure and whether this relationship of rhythmicity of MRproANP levels and nocturnal blood pressure differed in obese and lean individuals and by race'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diurnal Rhythm', 'Race'], 'conditions': ['Natriuretic Peptides', 'Obesity', 'Nocturnal Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '22282468', 'type': 'BACKGROUND', 'citation': 'Goetze JP, Jorgensen HL, Sennels HP, Fahrenkrug J. Diurnal plasma concentrations of natriuretic propeptides in healthy young males. Clin Chem. 2012 Apr;58(4):789-92. doi: 10.1373/clinchem.2011.178921. Epub 2012 Jan 26. No abstract available.'}, {'pmid': '25595796', 'type': 'BACKGROUND', 'citation': 'Arora P, Reingold J, Baggish A, Guanaga DP, Wu C, Ghorbani A, Song Y, Chen-Tournaux A, Khan AM, Tainsh LT, Buys ES, Williams JS, Heublein DM, Burnett JC, Semigran MJ, Bloch KD, Scherrer-Crosbie M, Newton-Cheh C, Kaplan LM, Wang TJ. Weight loss, saline loading, and the natriuretic peptide system. J Am Heart Assoc. 2015 Jan 16;4(1):e001265. doi: 10.1161/JAHA.114.001265.'}, {'pmid': '29167879', 'type': 'BACKGROUND', 'citation': 'Bajaj NS, Gutierrez OM, Arora G, Judd SE, Patel N, Bennett A, Prabhu SD, Howard G, Howard VJ, Cushman M, Arora P. Racial Differences in Plasma Levels of N-Terminal Pro-B-Type Natriuretic Peptide and Outcomes: The Reasons for Geographic and Racial Differences in Stroke (REGARDS) Study. JAMA Cardiol. 2018 Jan 1;3(1):11-17. doi: 10.1001/jamacardio.2017.4207.'}, {'pmid': '26892417', 'type': 'BACKGROUND', 'citation': 'Arora P, Wu C, Hamid T, Arora G, Agha O, Allen K, Tainsh RET, Hu D, Ryan RA, Domian IJ, Buys ES, Bloch DB, Prabhu SD, Bloch KD, Newton-Cheh C, Wang TJ. Acute Metabolic Influences on the Natriuretic Peptide System in Humans. J Am Coll Cardiol. 2016 Feb 23;67(7):804-812. doi: 10.1016/j.jacc.2015.11.049.'}, {'pmid': '33958126', 'type': 'RESULT', 'citation': 'Parcha V, Patel N, Gutierrez OM, Li P, Gamble KL, Musunuru K, Margulies KB, Cappola TP, Wang TJ, Arora G, Arora P. Chronobiology of Natriuretic Peptides and Blood Pressure in Lean and Obese Individuals. J Am Coll Cardiol. 2021 May 11;77(18):2291-2303. doi: 10.1016/j.jacc.2021.03.291.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study to assess the diurnal rhythm in natriuretic peptide levels and its temporal relationship with nocturnal blood pressure in obese and African-American individuals as compared with lean and white individuals.', 'detailedDescription': 'Obese and African-American individuals are at greater risk for cardiovascular morbidity and mortality than lean and white individuals. One of the key reasons for this health disparity is a higher risk of hypertension among obese and African-American individuals. The reasons for why these disparities develop are not well understood.\n\nNatriuretic peptides are hormones produced by the heart and have a wide range of favorable cardiovascular effects such as natriuresis (sodium excretion), vasodilation, and direct inhibition of the renin-angiotensin-aldosterone system. Human studies showed the existence of 24-hour (diurnal) variations in the circulating natriuretic peptide levels.\n\nPrior work from the investigators and others demonstrated that individuals with genetically-determined lower circulating natriuretic peptides levels have higher blood pressure and greater risk of hypertension. Further, the investigators have shown that obesity and African-American race are associated with lower natriuretic peptide levels, suggesting that relatively low natriuretic peptide levels may be a biologic determinant contributing to health disparities.\n\nObese and African-American individuals have a greater prevalence of nocturnal hypertension \\[nighttime blood pressure \\>120/80 mmHg\\], which is an independent risk factor for cardiovascular events. The underlying reasons for 24-hour variations in blood pressure are unknown.\n\nThe investigators hypothesize that loss of the natural 24-hour rhythm of natriuretic peptide levels plays a role in the development of nocturnal hypertension in obese and African-American individuals. The aims of this study are:\n\n1. to examine whether there is a presence of a 24-hour rhythm in natriuretic peptide levels among normotensive obese and African-American individuals and whether there is a difference in the rhythmicity of natriuretic peptide levels between obese and lean as well as in African-Americans and whites;\n2. to examine whether there is an existence of a relationship between 24-hour variability of natriuretic peptide levels and 24-hour patterns of blood pressure and whether this relationship of rhythmicity of natriuretic peptide levels and nocturnal blood pressure differed in obese and lean individuals and by race.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 40 years\n* Blood pressure less than 140/90\n* Body Mass Index between 18.5 to 25 kg/m2 (lean) or 30 to 45 kg/m2 (obese)\n* Self identified African-American or white individuals\n* Willingness to comply with the study diet\n* Provide informed consent\n\nExclusion Criteria:\n\n* History of hypertension\n* History of cardiovascular, renal, or liver disease\n* Diabetes or use of glucose-lowering medications\n* Use of vasoactive or diuretic medications\n* Atrial fibrillation\n* Anemia (Hematocrit \\<41%)\n* Abnormal serum sodium or potassium\n* Abnormal liver function tests (\\>3x upper limit of normal)\n* Current smokers\n* Regular users of non-steroid anti-inflammatory medications'}, 'identificationModule': {'nctId': 'NCT03834168', 'briefTitle': 'The Diurnal Rhythm in Natriuretic Peptide Levels', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'The Diurnal Rhythm in Natriuretic Peptide Levels and Relationship With Nocturnal Blood Pressure', 'orgStudyIdInfo': {'id': 'IRB-300002114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Study Individuals', 'description': 'Healthy self-identified African-American and white male participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).', 'interventionNames': ['Other: standardized Study Diet']}], 'interventions': [{'name': 'standardized Study Diet', 'type': 'OTHER', 'description': 'Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.', 'armGroupLabels': ['Study Individuals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Pankaj Arora, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Orlando M Gutierrez, MMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Pankaj Arora, MD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}