Prediabetes / Type 2 Diabetes
Conditions
Brief summary
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
Interventions
DRUGMetformin
16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.
DRUGGLP-1A
16 weeks using GLP1a: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.
DIETARY_SUPPLEMENTMED
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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | At month 0, month 4, month 8, month 11, month 15, month 18 | Compare efficacy of each treatment in change in body weight (kg). |
| Change in Blood Pressure | At month 0, month 4, month 8, month 11, month 15, month 18 | Compare efficacy of each treatment in change in blood pressure. |
| Change in LDL Cholesterol | At month 0, month 4, month 8, month 11, month 15, month 18 | Change in LDL cholesterol at the beginning and end of each intervention to compare the efficacy of each treatment. |
| Change in Triglycerides | At month 0, month 4, month 8, month 11, month 15, month 18 | Change in triglycerides at the beginning and end of each intervention period to compare the efficacy of each treatment. |
| Change in high-sensitivity C-reactive protein (hsCRP) | At month 0, month 4, month 8, month 11, month 15, month 18 | hsCRP will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment. |
| Change in Time in Range (TIR) | At month 0, month 4, month 8, month 11, month 15, month 18 | 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. |
| Change in adiponectin | At month 0, month 4, month 8, month 11, month 15, month 18 | Adiponectin will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment. |
| HOMA-B | At month 0, month 4, month 8, month 11, month 15, month 18 | Change from baseline in HOMA-B at the beginning and end of each intervention period to compare the efficacy of each treatment. |
| HOMA-IR | At month 0, month 4, month 8, month 11, month 15, month 18 | Change from baseline in HOMA-IR at the beginning and end of each intervention period to compare the efficacy of each treatment. |
| Change in body fat mass | At month 0, month 4, month 8, month 11, month 15, month 18 | 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. |
| Change in alanine transaminase (ALT) | At month 0, month 4, month 8, month 11, month 15, month 18 | ALT will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment. |
Countries
United States
Contacts
Primary ContactAlina Choi, BS
Backup ContactJasmine Yang, BA
Outcome results
None listed