Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-28 @ 7:35 PM
Study NCT ID:
NCT04406402
Status:
COMPLETED
Last Update Posted:
2020-06-02
First Post:
2020-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
L-arginine and Asymmetric Dimethylarginine (ADMA) and Lifestyle Protocols
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2008-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-30', 'studyFirstSubmitDate': '2020-05-25', 'studyFirstSubmitQcDate': '2020-05-25', 'lastUpdatePostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum L-arginine change', 'timeFrame': 'For acute phase: before the nutritional/exercise load (time 0), as well as 30, 60, 90, 120 and 150 minutes after the challenge test. And from baseline to 12 weeks for lifestyle modification phase', 'description': 'Change in arginine levels (absolute and relative) (µmol/l)'}, {'measure': 'High asymmetric dimethylarginine (ADMA) change', 'timeFrame': 'For acute phase: before the nutritional/exercise load (time 0), as well as 30, 60, 90, 120 and 150 minutes after the challenge test. And from baseline to 12 weeks for lifestyle modification phase', 'description': 'Change in ADMA levels (absolute and relative) (µmol/l)'}], 'secondaryOutcomes': [{'measure': 'Body mass index (BMI) change', 'timeFrame': 'From baseline to 12 weeks for lifestyle modification phase', 'description': 'Change in BMI levels (Kg/m2)'}, {'measure': 'Glycated hemoglobin (HbA1c) change', 'timeFrame': 'From baseline to 12 weeks for lifestyle modification phase', 'description': 'Change in HbA1c levels (%)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Obesity', 'Arginine', 'Asymmetric Dimethylarginine']}, 'referencesModule': {'references': [{'pmid': '35708634', 'type': 'DERIVED', 'citation': 'Buch A, Ganz T, Wainstein J, Gilad S, Limor R, Shefer G, Boaz M, Stern N. Alcohol Drinks Induce Acute Lowering in Circulating l-Arginine in Obese and Type 2 Diabetic Subjects. J Med Food. 2022 Jun;25(6):675-682. doi: 10.1089/jmf.2021.0045.'}]}, 'descriptionModule': {'briefSummary': 'Low serum L-arginine (Arg) and high asymmetric dimethylarginine (ADMA) can predict microvascular complications in type 2 diabetes (T2DM). The investigators examined whether or not Arg and ADMA are affected by dietary factors or lifestyle modification in overweight/ obese and T2DM subjects.', 'detailedDescription': 'The investigators tested the effects on serum Arg and ADMA of a) a single load of ingested dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard dietary and physical activity counseling in obese or T2DM subjects on circulating Arg and ADMA (n=43)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obese and/ or T2DM subjects\n\nExclusion Criteria:\n\n* type 1 diabetes\n* insulin-treated T2DM\n* active coronary disease (recent \\[≤ 6months\\] myocardial infarction, unstable angina, recent coronary catheterization, or coronary bypass grafting\n* individuals with significant impairment in liver enzymes (≥ 2.5 the upper limit of the normal range)\n* serum creatinine higher than 1.5mg%\n* known malabsorption, alcoholism or illicit use of drugs\n* abnormal thyroid function tests\n* concomitant or recent use of glucocorticoids\n* uncertain mental state (to avoid invalid informed consent or lack of compliance).'}, 'identificationModule': {'nctId': 'NCT04406402', 'briefTitle': 'L-arginine and Asymmetric Dimethylarginine (ADMA) and Lifestyle Protocols', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'The Effects of Different Acute Nutritional Protocols and Lifestyle Modification on Circulating L-arginine and Asymmetric Dimethylarginine (ADMA) in Obese and Type 2 Diabetic Subjects', 'orgStudyIdInfo': {'id': '03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acute glucose tolerance test', 'description': 'A standard oral glucose tolerance test (75 grams of dextrose in 180 cc of water)', 'interventionNames': ['Behavioral: Acute dietary protocols and lifestyle modification']}, {'type': 'EXPERIMENTAL', 'label': 'Acute protein load test', 'description': 'A protein-rich, vanilla-flavored powder (Pro-gym, Telpharma, Is', 'interventionNames': ['Behavioral: Acute dietary protocols and lifestyle modification']}, {'type': 'EXPERIMENTAL', 'label': 'Acute fat load test', 'description': 'a 100-gram portion of sweet cream containing 300 Kacls, of which 94% of the ingested calories were fat', 'interventionNames': ['Behavioral: Acute dietary protocols and lifestyle modification']}, {'type': 'EXPERIMENTAL', 'label': 'Acute alcohol load test', 'description': 'Vodka (100 cc, 40% alcohol)', 'interventionNames': ['Behavioral: Acute dietary protocols and lifestyle modification']}, {'type': 'EXPERIMENTAL', 'label': 'Acute exercise', 'description': "30 minutes of supervised graded walking on a treadmill according to each subject's individual ability. A goal heart rate was calculated as 70% of the age-adjusted maximal allowable heart rate.", 'interventionNames': ['Behavioral: Acute dietary protocols and lifestyle modification']}, {'type': 'EXPERIMENTAL', 'label': 'Lifestyle modification program - 12 weeks', 'description': '12 weeks of weight-loss dietary program constructed according to the guidelines of the American Diabetes Association. Based on weight, gender, and age, daily dietary allowance varied at 1200-1800 Kcal, 50% carbohydrates, 20% protein, and 30% fat. Participants were also asked to engage in moderate physical activity comprised of a 40-minute walk three times a week. A weekly clinic visit alternating with a weekly telephone contact was also required.', 'interventionNames': ['Behavioral: Acute dietary protocols and lifestyle modification']}], 'interventions': [{'name': 'Acute dietary protocols and lifestyle modification', 'type': 'BEHAVIORAL', 'description': 'The investigators tested the effects on serum Arg and ADMA of a) a single load of ingested dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard dietary and physical activity counseling in obese or T2DM subjects on circulating Arg and ADMA (n=43).', 'armGroupLabels': ['Acute alcohol load test', 'Acute exercise', 'Acute fat load test', 'Acute glucose tolerance test', 'Acute protein load test', 'Lifestyle modification program - 12 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5822012', 'city': 'Holon', 'country': 'Israel', 'facility': 'Diabetes Unit, E. Wolfson Medical Center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}], 'overallOfficials': [{'name': 'Naftali Stern, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel-Aviv Sourasky Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}