Heterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention

NCT06682351 Phase 4 NOT_YET_RECRUITING

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

Details

Lead sponsor	Stanford University
Phase	Phase 4
Status	NOT_YET_RECRUITING
Enrolment	200
Start date	2024-11
Completion	2027-12

Conditions

• Prediabetes / Type 2 Diabetes

Interventions

• Metformin
• GLP-1A
• MED

Primary outcomes

• Change in HbA1c — At month 0, month 4, month 8, month 11, month 15, month 18
  The study team will compare the change in HbA1c levels from beginning to end of intervention to compare the efficacy of each treatment.

Countries

United States