Early Phase 1
N=109
Metformin to Augment Strength Training Effective Response in Seniors (MASTERS)
Aging
Bottom Line
View on ClinicalTrials.gov: NCT02308228 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Percent Change in Type 2 Myofiber Cross Sectional Area — 18.5; 14.5 Percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Progressive Resistance Training (Behavioral); Metformin (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Philip Kern
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Type 2 Myofiber Cross Sectional Area |
18.5; 14.5 | — |
| SECONDARY Percent Change in Normal Density Muscle Size by Computed Tomography |
4.2; 10.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- ≥65 years of age.
- Independently mobile with a SPPB score 3-12.
- Access to transportation.
- Capable of providing informed consent (cognitively intact).
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT02308228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.