Metformin and Muscle in Insulin-resistant Older Veterans (M&M)
Sarcopenia is the loss of muscle mass, strength and function with aging and is associated with increased disability, falls and fractures. Older adults with diabetes and prediabetes are insulin resistant and have a higher risk of developing sarcopenia. This study examines the use of metformin, an antidiabetic drug, for preventing the development of sarcopenia in older adults with prediabetes.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
|Official Title:||Metformin and Muscle in Insulin-resistant Older Veterans|
- Change in total and appendicular lean mass [ Time Frame: 3 years ] [ Designated as safety issue: No ]At baseline, 1, 2, and 3 year follow-up visits, participants will have whole body dual x-ray absorptiometry scans (DXA) with a Hologic QDR 4500W DXA scanner by a certified DXA operator to determine total body lean mass and appendicular lean mass (Kg).
- Change in physical performance [ Time Frame: 3 years ] [ Designated as safety issue: No ]At baseline, 1, 2, and 3 year follow-up visits, participants will have physical performance tests assessed including: (1) 6 meter timed walk, (2) 400 meter timed walk, (3) grip strength measured with a Jamar dynamometer, (4) timed task of rising from a chair 5 times in succession without use of arms, (5) timed tandem, semi-tandem and side-by-side stands.
- Change in muscle histologic characteristics [ Time Frame: 1 year ] [ Designated as safety issue: No ]At baseline and 1 year follow-up visits, 32 subjects will undergo a muscle biopsy of the vastus lateralis muscle 15 cm above the patella using the modified Bergstrom technique under local anesthesia. The muscle biopsy specimens will be used for the following histologic measurements: (1) mitochondrial content, (2) triglyceride content, (3) capillary density, and (4) quantification of Type I, IIa and IIx muscle fibers.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||February 2018 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
60 participants will be randomized to placebo pills.
One placebo capsule by mouth once daily for 1 month followed by one placebo capsule by mouth twice daily for the remainder of the study.
Active Comparator: Metformin
60 enrolled participants will be randomized to metformin.
Metformin will be given at a dose of 850 mg orally once daily for 1 month with titration up to 850 mg orally twice daily for the remainder of the study.
Other Name: Glucophage
The proposed study utilizes clinical and translational research approaches to study sarcopenia. Sarcopenia is common in older adults and is associated with decreased strength, increased disability, falls and fractures. There are currently few interventions to prevent or treat sarcopenia and a poor understanding of the mechanisms for sarcopenia. Given the growing number of veterans over the age of 65, studies to prevent sarcopenia and resulting disability are important for the health, independence and well-being of this population. Our preliminary studies have shown that older adults with diabetes have an accelerated loss in muscle mass and gait speed, except when treated with metformin. Older adults with prediabetes also have a greater decline in muscle mass and higher incidence of disability. Therefore, this study further investigates these findings by addressing the following aims: (1) to determine whether metformin can prevent the loss in muscle mass and physical performance and (2) to examine changes in muscle histologic characteristics associated with metformin treatment in older adults with prediabetes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01804049
|Contact: Christine G Lee, MD||Christine.Lee8@va.gov|
|Contact: Carrie Farrar, MPH||(503) firstname.lastname@example.org|
|United States, Oregon|
|VA Portland Health Care System, Portland, OR||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Michael P Davey, MD PhD 503-273-5125 email@example.com|
|Principal Investigator: Christine G. Lee, MD|
|Principal Investigator:||Christine G. Lee, MD||VA Portland Health Care System, Portland, OR|