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Clinical Trial Details

Trial ID: L7321
Source ID: NCT06682351
Associated Drug: Metformin
Title: Heterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Prediabetes / Type 2 Diabetes
Interventions: DRUG: Metformin|DRUG: GLP-1A|DIETARY_SUPPLEMENT: MED
Outcome Measures: Primary: Change in HbA1c, The study team will compare the change in HbA1c levels from beginning to end of intervention to compare the efficacy of each treatment., At month 0, month 4, month 8, month 11, month 15, month 18 | Secondary: Change in Time in Range (TIR), 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., At month 0, month 4, month 8, month 11, month 15, month 18|Change in body weight, Compare efficacy of each treatment in change in body weight (kg)., At month 0, month 4, month 8, month 11, month 15, month 18|Change in Blood Pressure, Compare efficacy of each treatment in change in blood pressure., At month 0, month 4, month 8, month 11, month 15, month 18|Change in LDL Cholesterol, Change in LDL cholesterol at the beginning and end of each intervention to compare the efficacy of each treatment., At month 0, month 4, month 8, month 11, month 15, month 18|Change in Triglycerides, Change in triglycerides at the beginning and end of each intervention period to compare the efficacy of each treatment., At month 0, month 4, month 8, month 11, month 15, month 18|Change in high-sensitivity C-reactive protein (hsCRP), hsCRP will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment., At month 0, month 4, month 8, month 11, month 15, month 18|Change in alanine transaminase (ALT), ALT will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment., At month 0, month 4, month 8, month 11, month 15, month 18|Change in adiponectin, Adiponectin will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment., At month 0, month 4, month 8, month 11, month 15, month 18|HOMA-B, Change from baseline in HOMA-B at the beginning and end of each intervention period to compare the efficacy of each treatment., At month 0, month 4, month 8, month 11, month 15, month 18|HOMA-IR, Change from baseline in HOMA-IR at the beginning and end of each intervention period to compare the efficacy of each treatment., At month 0, month 4, month 8, month 11, month 15, month 18|Change in body fat mass, 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., At month 0, month 4, month 8, month 11, month 15, month 18
Sponsor/Collaborators: Sponsor: Stanford University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 200
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2027-12
Results First Posted:
Last Update Posted: 2024-11-12
Locations: Stanford University, Stanford, California, 94305, United States
URL: https://clinicaltrials.gov/show/NCT06682351