Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-23 @ 12:19 PM
Study NCT ID:
NCT06682351
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-12
First Post:
2024-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'C055453', 'term': 'glucagon-like peptide 1 (7-36)amide'}, {'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D038441', 'term': 'Diet, Mediterranean'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2024-11-07', 'studyFirstSubmitQcDate': '2024-11-07', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'At month 0, month 4, month 8, month 11, month 15, month 18', 'description': 'The study team will compare the change in HbA1c levels from beginning to end of intervention to compare the efficacy of each treatment.'}], 'secondaryOutcomes': [{'measure': 'Change in Time in Range (TIR)', 'timeFrame': 'At month 0, month 4, month 8, month 11, month 15, month 18', 'description': 'Change in Time in Rage (TIR) as measured by continuous glucose monitor (CGM). TIR is defined as a range of 70-140 mg/dL. The study team will calculate the changes from beginning to end or each intervention and compare efficacy of each treatment in TIR.'}, {'measure': 'Change in body weight', 'timeFrame': 'At month 0, month 4, month 8, month 11, month 15, month 18', 'description': 'Compare efficacy of each treatment in change in body weight (kg).'}, {'measure': 'Change in Blood Pressure', 'timeFrame': 'At month 0, month 4, month 8, month 11, month 15, month 18', 'description': 'Compare efficacy of each treatment in change in blood pressure.'}, {'measure': 'Change in LDL Cholesterol', 'timeFrame': 'At month 0, month 4, month 8, month 11, month 15, month 18', 'description': 'Change in LDL cholesterol at the beginning and end of each intervention to compare the efficacy of each treatment.'}, {'measure': 'Change in Triglycerides', 'timeFrame': 'At month 0, month 4, month 8, month 11, month 15, month 18', 'description': 'Change in triglycerides at the beginning and end of each intervention period to compare the efficacy of each treatment.'}, {'measure': 'Change in high-sensitivity C-reactive protein (hsCRP)', 'timeFrame': 'At month 0, month 4, month 8, month 11, month 15, month 18', 'description': 'hsCRP will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment.'}, {'measure': 'Change in alanine transaminase (ALT)', 'timeFrame': 'At month 0, month 4, month 8, month 11, month 15, month 18', 'description': 'ALT will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment.'}, {'measure': 'Change in adiponectin', 'timeFrame': 'At month 0, month 4, month 8, month 11, month 15, month 18', 'description': 'Adiponectin will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment.'}, {'measure': 'HOMA-B', 'timeFrame': 'At month 0, month 4, month 8, month 11, month 15, month 18', 'description': 'Change from baseline in HOMA-B at the beginning and end of each intervention period to compare the efficacy of each treatment.'}, {'measure': 'HOMA-IR', 'timeFrame': 'At month 0, month 4, month 8, month 11, month 15, month 18', 'description': 'Change from baseline in HOMA-IR at the beginning and end of each intervention period to compare the efficacy of each treatment.'}, {'measure': 'Change in body fat mass', 'timeFrame': 'At month 0, month 4, month 8, month 11, month 15, month 18', 'description': 'Body fat mass will be measured by dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of each intervention period to compare the efficacy of each treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prediabetes / Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The study team will invite participants with prediabetes or mild diabetes (HbA1c 5.7-7.0) to join a 5-year research study that will define subphenotypes of type 2 diabetes based on underlying physiology (eg insulin resistance, beta-cell dysfunction, incretin defect, liver insulin resistance) and then test the hypothesis that response to three first-line treatments will vary according to metabolic subphenotype. Variables of interest include glucose, cardiovascular risk markers, and weight. Treatments include Mediterranean diet, metformin, and a GLP-1 agonist. Participants will go through an initial screening, followed by three treatment periods, each lasting 4 months with 3 month washout in-between treatment periods. This study will help us understand how personalized treatments can help control blood glucose, reduce cardiovascular risk, and manage weight. While there may be minor side effects-like slight discomfort from blood tests, gastrointestinal symptoms from some of the medications, and small radiation exposure from DXA body scans-the treatments offered in this study have all been well studied and are known to lower risk for diabetes and cardiovascular disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≥23 (≥22 in Asians) kg/m2 but \\< 45 kg/m2\n* HbA1c 5.7-8.0% while not on antihyperglycemic medications\n\nExclusion Criteria:\n\n* Recent (\\<6mos) CVD event\n* active malignancy, kidney/liver disease pregnancy/lactation, chronic inflammatory disease, eating disorder, bariatric surgery\n* history of acute pancreatitis\n* family or personal history of medullary thyroid cancer\n* current use of antihyperglycemic, diabetogenic, or weight loss medications (washout allowed if approved by primary physician)\n* heavy alcohol use\n* hct \\<30, creatinine \\> 1.4, ALT\\> 3x ULN\n* physical activity \\>2 hours/day\n* inability to come to Stanford CTRU for metabolic testing'}, 'identificationModule': {'nctId': 'NCT06682351', 'briefTitle': 'Heterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Heterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention', 'orgStudyIdInfo': {'id': '76481'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mediterranean Diet/GLP1a/Metformin', 'description': '1. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.\n2. 3 months washout\n3. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.\n4. 3 months washout\n5. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.', 'interventionNames': ['Drug: Metformin', 'Drug: GLP-1A', 'Dietary Supplement: MED']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin/Mediterranean Diet/GLP1a', 'description': '1. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.\n2. 3 months washout\n3. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.\n4. 3 months washout\n5. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.', 'interventionNames': ['Drug: Metformin', 'Drug: GLP-1A', 'Dietary Supplement: MED']}, {'type': 'EXPERIMENTAL', 'label': 'GLP1a/Metformin/Mediterranean Diet', 'description': '1. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.\n2. 3 months washout\n3. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.\n4. 3 months washout\n5. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.', 'interventionNames': ['Drug: Metformin', 'Drug: GLP-1A', 'Dietary Supplement: MED']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['MET'], 'description': '16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.', 'armGroupLabels': ['GLP1a/Metformin/Mediterranean Diet', 'Mediterranean Diet/GLP1a/Metformin', 'Metformin/Mediterranean Diet/GLP1a']}, {'name': 'GLP-1A', 'type': 'DRUG', 'otherNames': ['Glucagon-like peptide-1 analog'], 'description': '16 weeks using GLP1a: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.', 'armGroupLabels': ['GLP1a/Metformin/Mediterranean Diet', 'Mediterranean Diet/GLP1a/Metformin', 'Metformin/Mediterranean Diet/GLP1a']}, {'name': 'MED', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Mediterranean Diet', 'energy-restricted Mediterranean diet'], 'description': '16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.', 'armGroupLabels': ['GLP1a/Metformin/Mediterranean Diet', 'Mediterranean Diet/GLP1a/Metformin', 'Metformin/Mediterranean Diet/GLP1a']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Alina Choi, BS', 'role': 'CONTACT', 'email': 'linachoi@stanford.edu'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'Alina Choi, BS', 'role': 'CONTACT', 'email': 'linachoi@stanford.edu', 'phone': '7144884516'}, {'name': 'Jasmine Yang, BA', 'role': 'CONTACT', 'email': 'jasminey@stanford.edu'}], 'overallOfficials': [{'name': 'Tracey McLaughlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine (Endocrinology)', 'investigatorFullName': 'Tracey McLaughlin', 'investigatorAffiliation': 'Stanford University'}}}}