Metformin to Augment Strength Training Effective Response in Seniors (MASTERS)

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Aging

In brief

The purpose of this study is to determine whether a commonly prescribed drug, metformin, can enhance the benefits seen during resistance exercise such as increased muscle mass and strength.

Key facts

Study ID

NCT02308228

Run by

Philip Kern

People needed

109

Starts

2015-01-14

Expected to finish

2018-06-28

Last updated by the study team

2019-09-17

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• ≥65 years of age.
• Independently mobile with a SPPB score 3-12.
• Access to transportation.
• Capable of providing informed consent (cognitively intact).

You may not qualify if…

• Obesity (BMI>30)
• Serum creatinine >1.4 because of risk of lactic acidosis with metformin.
• History of regular resistance training within the past year.
• History (or ECG evidence) of previous myocardial infarction, history of congestive heart failure.
• Current angina pectoris or symptoms of myocardial ischemia or congestive heart failure.
• Chronic aspirin or NSAID use (unless it can be safely stopped prior to the biopsies), and any other use of an anticoagulant (e.g., Coumadin) or history of bleeding.
• History of alcoholism or liver disease.
• History of hypo- or hyper-coagulation disorders including subjects taking Coumadin.
• Any end-stage disease and/or a life expectancy less than one year.
• Neurological, musculoskeletal, or other disorder that would preclude them from completing resistance training and all performance tests.
• Uncontrolled hypertension.
• Diabetes mellitus as demonstrated with- HgbA1C>6.5, or fasting glu>126 mg/dl.
• Any other medical condition that would interfere with testing or increase one's risk of complications during exercise, as judged by the study physicians.
• Any other condition or events considered exclusionary by the PI and/or physician, such as non-compliance.
• Lidocaine allergy (1% lidocaine is the local anesthetic used during the muscle biopsy procedure).

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• University of Kentucky — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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