Status:
COMPLETED
Metformin to Augment Strength Training Effective Response in Seniors (MASTERS)
Lead Sponsor:
Philip Kern
Collaborating Sponsors:
University of Alabama at Birmingham
Conditions:
Aging
Eligibility:
All Genders
65+ years
Phase:
EARLY_PHASE1
Brief Summary
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.
Detailed Description
Muscle mass and strength are critical determinants not only of a person's quality of life and functional independence, but also metabolic health, as muscle is the organ primarily responsible for insul...
Eligibility Criteria
Inclusion
- ≥65 years of age.
- Independently mobile with a SPPB score 3-12.
- Access to transportation.
- Capable of providing informed consent (cognitively intact).
Exclusion
- 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).
Key Trial Info
Start Date :
January 14 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2018
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT02308228
Start Date
January 14 2015
End Date
June 28 2018
Last Update
September 17 2019
Active Locations (2)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
2
University of Kentucky
Lexington, Kentucky, United States, 40536