What this trial means for you
This study is opening soon at 1 US site. It's studying Metformin, GLP-1A for prediabetes / type 2 diabetes.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
Inclusion Criteria: * BMI ≥23 (≥22 in Asians) kg/m2 but \< 45 kg/m2 * HbA1c 5.7-8.0% while not on antihyperglycemic medications Exclusion Criteria: * Recent (\<6mos) CVD event * active malignancy, kidney/liver disease pregnancy/lactation, chronic inflammatory disease, eating disorder, bariatric surgery * history of acute pancreatitis * family or personal history of medullary thyroid cancer * current use of antihyperglycemic, diabetogenic, or weight loss medications (washout allowed if approved by primary physician) * heavy alcohol use * hct \<30, creatinine \> 1.4, ALT\> 3x ULN * physical activity \>2 hours/day * inability to come to Stanford CTRU for metabolic testing
Study sites by state
California
- Stanford University — Stanford
View the official record on ClinicalTrials.gov →
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