Evaluation of the Metformin Effect on Methylglyoxal in Patients With Type 2 Diabetes (MET)
Type 2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Metformin, diabetes, type 2 diabetes, diabetes complications, methylglyoxal, Prediabetes
Eligibility Criteria
Inclusion Criteria:
- Elevated HbA1c > 6.0% (patients with type 2 diabetes mellitus or prediabetes), HbA1C < 9.0%
- For matched non-diabetic patients: HbA1C ≤ 5.6%
- Serum creatinine (SCr) < 1.5 mg/dL in males or < 1.4 mg/dL in females,
- Calculated glomerular filtration rate (GFR) > 60 ml/min/1.73m2,
- Body mass index (BMI) 25-40 kg/m2,
- Glycosylated hemoglobin A1C (HA1C) < 9%,
- No known intolerance to metformin
- Has not taken metformin previous 3 months
Exclusion Criteria:
- Patients on thiazolidinediones (TZD)
- Patients with history of metformin intolerance (gastrointestinal side effects or poor renal function; Serum Cr > 1.5mg/dL in males or > 1.4 mg/dL in females or calculated GFR < 60 mL/min/1.73m2
- Patients with active (symptomatic or unstable) cardiovascular disease
- Patients requiring home oxygen
- Patients with end-stage liver disease (cirrhosis)
- Patients on oral glucocorticoids within the past 30 days (equivalent to prednisone > 5mg/day)
- Excessive alcohol intake (The Substance Abuse and Mental Health Services Administration (SAMHSA) defines heavy drinking as drinking 5 or more drinks on the same occasion on each of 5 or more days in the past 30 days) 29
- Pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Placebo Comparator
Other
Treatment (Metformin)
Placebo
Non-diabetic
Forty patients with elevated glycosylated hemoglobin A1c (HbA1c) > 6.0% (patients with type 2 diabetes mellitus or prediabetes) but HbA1C < 9.0%. They will receive the active comparator (metformin).
Forty patients with elevated glycosylated hemoglobin A1c (HbA1c) > 6.0% (patients with type 2 diabetes mellitus or prediabetes) but HbA1C < 9.0%. They will receive the placebo comparator.
Forty matched non-diabetic patients with HbA1C ≤ 5.6%. They will not receive either treatment (metformin) or placebo.