Evaluation of the Metformin Effect on Methylglyoxal in Patients With Type 2 Diabetes

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to investigate the effects of metformin, a commonly prescribed first line medication for diabetes and recommended for prediabetes, on the levels of the potentially tissue damaging reactive product (MG) in the blood and its cleared counterpart in the urine (IMZ). The study will involve patients with elevated HbA1c randomized to receive either metformin or a similar inactive placebo pill and a group of sex and age matched volunteers without diabetes. Study participants will be recruited from the University of Arizona Medical Center, South Campus clinics (Endocrine clinic, family medicine clinic and general medicine clinic). Eighty patients with HbA1c >6.0% will be randomized to receive either metformin or a similar inactive placebo for 6 weeks. The response of these patients will be compared to 40 patients normal HbA1c <5.6% who will not receive either study medication. Investigators will compare the plasma MG and urine IMZ concentration/content between the 3 groups before and after the 6-week intervention. It is hypothesized that plasma MG level in the metformin treatment group will be less than in the group taking the placebo pills, while there will be no significant difference in MG level between the metformin treatment group and the volunteers without diabetes.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Arizona
• Treatments: Calcium; Calcium Carbonate; Metformin

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