Metformin to Augment Strength Training Effective Response in Seniors (MASTERS)
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ClinicalTrials.gov Identifier: NCT02308228 |
Recruitment Status :
Completed
First Posted : December 4, 2014
Results First Posted : September 17, 2019
Last Update Posted : September 17, 2019
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Condition or disease | Intervention/treatment | Phase |
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Aging | Behavioral: Progressive Resistance Training Drug: Metformin | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 109 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | Novel Actions of Metformin to Augment Resistance Training Adaptations in Older Adults |
Actual Study Start Date : | January 14, 2015 |
Actual Primary Completion Date : | December 14, 2017 |
Actual Study Completion Date : | June 28, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Metformin
Participants will be randomized to receive Metformin (1700 mg/day) for a period of 16 weeks; 2 weeks of Metformin only followed by 14 weeks of continued Metformin use in combination with progressive resistance training.
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Behavioral: Progressive Resistance Training
Participants will complete 14 weeks (42 sessions, 3x/week) of progressive resistance training which will consist of 8 constant load movements to train all major muscle groups bilaterally.
Other Name: Strength Training Drug: Metformin Participants will be randomized to receive metformin in conjunction with their strength training program.
Other Name: Glucophage XR |
Placebo Comparator: Placebo, Sugar Pill
Participants will be randomized to receive placebo sugar pills (1700 mg/day) for a period of 16 weeks; 2 weeks of placebo only followed by 14 weeks of continued placebo use in combination with progressive resistance training. Placebos will be almost identical to the Metformin medication.
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Behavioral: Progressive Resistance Training
Participants will complete 14 weeks (42 sessions, 3x/week) of progressive resistance training which will consist of 8 constant load movements to train all major muscle groups bilaterally.
Other Name: Strength Training |
- Percent Change in Type 2 Myofiber Cross Sectional Area [ Time Frame: 16 weeks ]The ability of metformin to improve the hypertrophic response to resistance training will be determined. Muscle biopsies of the vastus lateralis will be used to quantify myofiber cross-sectional area. The percent change in type 2 myofiber size between week 16 and week 0 was used.
- Percent Change in Normal Density Muscle Size by Computed Tomography [ Time Frame: 16 weeks ]The ability of metformin to improve the hypertrophic response at the whole muscle level will be quantified by computed tomography. Percent change in normal density muscle area will be calculated as the difference between week 16 and week 0.
- Percent Change in Muscle Strength [ Time Frame: Week 4 and week 16 ]Determine if metformin treatment augments strength gains in conjunction with progressive resistance training by one repetition maximum assessments. Maximum (1RM) leg extension muscle strength was assessed at week 4 (to account for neurological adaptations during the initial stages of the resistance program) and week 16. The percent change from week 4 to week 16 is reported.
- Percent Change in Total Body Lean Mass by DXA [ Time Frame: 16 weeks ]To determine if metformin improves changes in body composition associated with progressive resistance training. Percent change in total body lean mass in kg was calculated as the difference between week 16 and week 0 from a total body DXA scan.
- Insulin Sensitivity [ Time Frame: 16 weeks ]A standard OGTT will be used to determine insulin sensitivity using the Matsuda Index.

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308228
United States, Alabama | |
University of Alabama Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, Kentucky | |
University of Kentucky | |
Lexington, Kentucky, United States, 40536 |
Principal Investigator: | Charlotte Peterson, Ph.D. | University of Kentucky | |
Principal Investigator: | Philip Kern, M.D. | University of Kentucky | |
Principal Investigator: | Marcas Bamman, Ph.D | University of Alabama at Birmingham |
Documents provided by Philip Kern, University of Kentucky:
Responsible Party: | Philip Kern, M.D., University of Kentucky |
ClinicalTrials.gov Identifier: | NCT02308228 |
Other Study ID Numbers: |
1R01AG046920-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | December 4, 2014 Key Record Dates |
Results First Posted: | September 17, 2019 |
Last Update Posted: | September 17, 2019 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Aging Hypertrophy Metformin Strength Muscle |
Metformin Hypoglycemic Agents Physiological Effects of Drugs |