Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-02-06 @ 1:56 AM
Study NCT ID:
NCT03469492
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2018-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose
Sponsor:
Organization:
Raw JSON
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Result reported is the mean decrease in HbA1C. A decrease in HbA1c indicates improvement in brain glucose levels.', 'unitOfMeasure': 'mmol/mol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gluthathione', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 2 Diabetes Mellitus', 'description': 'Subjects with type 2 diabetes on insulin.\n\nInsulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.\n\nexercise: Exercise in accordance to the guidelines established by the American Diabetes Association.\n\nDietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.'}], 'timeFrame': '0 weeks', 'description': 'baseline MRS scan to measure gluthathione', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome not collected.'}, {'type': 'SECONDARY', 'title': 'Gluthathione', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 2 Diabetes Mellitus', 'description': 'Subjects with type 2 diabetes on insulin.\n\nInsulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.\n\nexercise: Exercise in accordance to the guidelines established by the American Diabetes Association.\n\nDietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.'}], 'timeFrame': '12 weeks', 'description': 'MRS scan to measure gluthathione', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome not collected.'}, {'type': 'SECONDARY', 'title': 'Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 2 Diabetes Mellitus', 'description': 'Subjects with type 2 diabetes on insulin.\n\nInsulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.\n\nexercise: Exercise in accordance to the guidelines established by the American Diabetes Association.\n\nDietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.07', 'spread': '.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks', 'description': 'MRS scan to measure plasma glucose', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 2 Diabetes Mellitus', 'description': 'Subjects with type 2 diabetes on insulin.\n\nInsulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.\n\nexercise: Exercise in accordance to the guidelines established by the American Diabetes Association.\n\nDietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.88', 'spread': '0.35', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.266', 'groupIds': ['OG000'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'MRS scan to measure plasma glucose', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Fructose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 2 Diabetes Mellitus', 'description': 'Subjects with type 2 diabetes on insulin.\n\nInsulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.\n\nexercise: Exercise in accordance to the guidelines established by the American Diabetes Association.\n\nDietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.'}], 'timeFrame': '0 weeks', 'description': 'MRS scan to measure plasma fructose', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome not collected.'}, {'type': 'SECONDARY', 'title': 'Plasma Fructose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 2 Diabetes Mellitus', 'description': 'Subjects with type 2 diabetes on insulin.\n\nInsulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.\n\nexercise: Exercise in accordance to the guidelines established by the American Diabetes Association.\n\nDietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.'}], 'timeFrame': '12 weeks', 'description': 'MRS scan to measure plasma fructose', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome not collected.'}, {'type': 'SECONDARY', 'title': 'Plasma Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 2 Diabetes Mellitus', 'description': 'Subjects with type 2 diabetes on insulin.\n\nInsulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.\n\nexercise: Exercise in accordance to the guidelines established by the American Diabetes Association.\n\nDietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '26', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.20', 'groupIds': ['OG000'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '0 weeks', 'description': 'MRS scan to measure plasma insulin', 'unitOfMeasure': 'μU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 2 Diabetes Mellitus', 'description': 'Subjects with type 2 diabetes on insulin.\n\nInsulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.\n\nexercise: Exercise in accordance to the guidelines established by the American Diabetes Association.\n\nDietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'spread': '29', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'MRS scan to measure plasma insulin', 'unitOfMeasure': 'μU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Optional Hyperglycemic Clamp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 2 Diabetes Mellitus', 'description': 'Subjects with type 2 diabetes on insulin.\n\nInsulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.\n\nexercise: Exercise in accordance to the guidelines established by the American Diabetes Association.\n\nDietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'upon enrollment', 'description': 'Hyperglycemic clamp administered to measure glucose levels. Data represented is the number of participants the clamp was used on successfully.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Type 2 Diabetes Mellitus', 'description': 'Subjects with type 2 diabetes on insulin.\n\nInsulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.\n\nexercise: Exercise in accordance to the guidelines established by the American Diabetes Association.\n\nDietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Type 2 Diabetes Mellitus', 'description': 'Subjects with type 2 diabetes on insulin.\n\nInsulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.\n\nexercise: Exercise in accordance to the guidelines established by the American Diabetes Association.\n\nDietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.8', 'spread': '8.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': '8.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'spread': '6.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms/meter square', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '85', 'spread': '21.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '84.1', 'spread': '16.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/mol', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'spread': '1.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage glycated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-14', 'size': 8939311, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-03T12:32', 'hasProtocol': True}, {'date': '2021-06-14', 'size': 254736, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-01T12:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-01', 'studyFirstSubmitDate': '2018-01-11', 'resultsFirstSubmitDate': '2022-11-18', 'studyFirstSubmitQcDate': '2018-03-16', 'lastUpdatePostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-18', 'studyFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Optional Hyperglycemic Clamp', 'timeFrame': 'upon enrollment', 'description': 'Hyperglycemic clamp administered to measure glucose levels. Data represented is the number of participants the clamp was used on successfully.'}], 'primaryOutcomes': [{'measure': 'Change in HbA1c Levels', 'timeFrame': 'Baseline and 12 weeks', 'description': 'HbA1c levels measured by MRS scanning during a hyperglycaemic clamp. Result reported is the mean decrease in HbA1C. A decrease in HbA1c indicates improvement in brain glucose levels.'}], 'secondaryOutcomes': [{'measure': 'Gluthathione', 'timeFrame': '0 weeks', 'description': 'baseline MRS scan to measure gluthathione'}, {'measure': 'Gluthathione', 'timeFrame': '12 weeks', 'description': 'MRS scan to measure gluthathione'}, {'measure': 'Plasma Glucose', 'timeFrame': '0 weeks', 'description': 'MRS scan to measure plasma glucose'}, {'measure': 'Plasma Glucose', 'timeFrame': '12 weeks', 'description': 'MRS scan to measure plasma glucose'}, {'measure': 'Plasma Fructose', 'timeFrame': '0 weeks', 'description': 'MRS scan to measure plasma fructose'}, {'measure': 'Plasma Fructose', 'timeFrame': '12 weeks', 'description': 'MRS scan to measure plasma fructose'}, {'measure': 'Plasma Insulin', 'timeFrame': '0 weeks', 'description': 'MRS scan to measure plasma insulin'}, {'measure': 'Plasma Insulin', 'timeFrame': '12 weeks', 'description': 'MRS scan to measure plasma insulin'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperglycaemia (Diabetic)']}, 'referencesModule': {'references': [{'pmid': '35247067', 'type': 'DERIVED', 'citation': 'Sanchez-Rangel E, Gunawan F, Jiang L, Savoye M, Dai F, Coppoli A, Rothman DL, Mason GF, Hwang JJ. Reversibility of brain glucose kinetics in type 2 diabetes mellitus. Diabetologia. 2022 May;65(5):895-905. doi: 10.1007/s00125-022-05664-y. Epub 2022 Mar 5.'}]}, 'descriptionModule': {'briefSummary': 'To investigate whether longer-term improvement of glycemic control in poorly controlled diabetes patients with a 12-week intensified insulin treatment regimen will lead to decreased polyol pathway activity.', 'detailedDescription': 'Polyol pathway activity will decrease in diabetic individuals who undergo intensification of their insulin treatment regimens as reflected by lower baseline brain intracellular fructose levels and higher intracellular glutathione levels. Furthermore, following longer-term improved glycemic control, patients may also have down-regulation of the pathway as reflected by decreased production of intracellular fructose in response to hyperglycemic clamp.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 15 Type 2 DM subjects with HbA1C \\> 7.5%\n* 15 Type 1 DM subjects with HbA1C \\> 7.5%\n* Age 18-60\n* BMI ≥18 kg/m2\n* Weight ≤ 285 pounds\n\nExclusion Criteria:\n\n* Creatinine \\> 1.5 mg/dL, Hgb \\< 10 mg/dL, ALT \\> 2.5 X ULN,\n* untreated thyroid disease,\n* uncontrolled hypertension,\n* known neurological disorders,\n* untreated psychiatric disorders,\n* malignancy,\n* bleeding disorders,\n* current or recent steroid use in last 3 months,\n* illicit drug use;\n* for women: pregnancy, actively seeking pregnancy, or breastfeeding; inability to enter\n* MRI/MRS'}, 'identificationModule': {'nctId': 'NCT03469492', 'briefTitle': 'Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose: an Intervention Study', 'orgStudyIdInfo': {'id': '1602017151'}, 'secondaryIdInfos': [{'id': '1K23DK109284-01', 'link': 'https://reporter.nih.gov/quickSearch/1K23DK109284-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'type 2 diabetes mellitus', 'description': 'Subjects with type 2 diabetes on insulin.', 'interventionNames': ['Drug: Insulin', 'Behavioral: exercise', 'Dietary Supplement: Dietary counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'type 1 diabetes mellitus', 'description': 'Subjects with type 1 diabetes on insulin.', 'interventionNames': ['Drug: Insulin', 'Behavioral: exercise', 'Dietary Supplement: Dietary counseling']}], 'interventions': [{'name': 'Insulin', 'type': 'DRUG', 'description': 'Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.', 'armGroupLabels': ['type 1 diabetes mellitus', 'type 2 diabetes mellitus']}, {'name': 'exercise', 'type': 'BEHAVIORAL', 'description': 'Exercise in accordance to the guidelines established by the American Diabetes Association.', 'armGroupLabels': ['type 1 diabetes mellitus', 'type 2 diabetes mellitus']}, {'name': 'Dietary counseling', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dietary counseling in accordance to the guidelines established by the American Diabetes Association.', 'armGroupLabels': ['type 1 diabetes mellitus', 'type 2 diabetes mellitus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'The Anylan Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Janice Hwang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Section of Endocrinology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}