A Phase 4 interventional study of Metformin and GLP-1A in Prediabetes / Type 2 Diabetes, sponsored by Stanford University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Stanford University · Phase 4, Interventional, and Treatment
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
1,021 studies on the registry are indexed under Prediabetic State; 242 are open to participants now.
This study's planned enrollment of 200 is above the median of 66 across 861 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 207 (77%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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. 2. 3 months washout 3. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols. 4. 3 months washout 5. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.
Drug: Metformin · Drug: GLP-1A · Dietary Supplement: MED
1. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week. 2. 3 months washout 3. 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. 4. 3 months washout 5. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.
Drug: Metformin · Drug: GLP-1A · Dietary Supplement: MED
1. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols. 2. 3 months washout 3. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week. 4. 3 months washout 5. 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.
Drug: Metformin · Drug: GLP-1A · Dietary Supplement: MED
16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.
Also known as: MET
16 weeks using GLP1a: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.
Also known as: Glucagon-like peptide-1 analog
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.
Also known as: Mediterranean Diet, energy-restricted Mediterranean diet
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.
Time frame: At month 0, month 4, month 8, month 11, month 15, month 18
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At month 0, month 4, month 8, month 11, month 15, month 18
Plan to share: No
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Studies of the drugs tested here: Metformin · Glucagon-like peptide 1 (7-36)amide