CompletedPhase 1

Metformin's Effect on Glucagon-induced Glucose Production and Protein Metabolism.

United States12 participantsStarted 2013-10

Plain-language summary

This study is being done to understand metformin's mechanisms of action regarding glucose production, protein metabolism, and mitochondrial function.

Who can participate

Age range

35 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: * 35-65 years of age * Fasting blood glucose \>100 mg/dl * BMI 27-36 kg/m2 * Waist Circumference: Men ≥ 104 cm; women ≥ 88 cm * If previously on anti-diabetic medication, should be off for at least 1 month Exclusion Criteria: * Active use of hypoglycemic agents (\< 1 month) * Renal failure, creatinine ≥ 1.5 mg/dL in men or ≥ 1.4 mg/dL in women * Alanine aminotransferase levels exceed 135 IU/L or aspartate aminotransferase levels exceed 129 IU/L (3 x the upper limit of normal) * Congestive Heart Failure (EF \< 40 %) * Active coronary artery disease * Recent (less than 6 weeks) or planned imaging study requiring IV contrast * Participation in structured exercise (\> 2 hr per week) * Recent change in dietary habits or weight * Tobacco use * Use of systemic glucocorticoids * Anti-coagulant therapy (warfarin/heparin) * Pregnancy or breastfeeding * Alcohol consumption greater than 2 drinks/day * Uncontrolled Hypothyroidism, abnormal thyroid stimulating hormone levels * Metformin Allergy

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

Change in Glucagon-induced endogenous glucose production.

Timeframe: Measured at week 0, 2, 4, 6 and 8

Trial details

NCT IDNCT01956929

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-03

View on ClinicalTrials.gov More Insulin Resistance trials

Who can participate

Age range

35 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.