Evaluation of the Metformin Effect on Methylglyoxal in Patients With Type 2 Diabetes (NCT02548741) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of the Metformin Effect on Methylglyoxal in Patients With Type 2 Diabetes
120 participantsStarted 2015-09
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma methylglyoxal (MG) concentration (μM)
Timeframe: Change from baseline in plasma MG concentration at 6 weeks of metformin administration