Metformin and Muscle in Insulin-resistant Older Veterans (M&M)
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|ClinicalTrials.gov Identifier: NCT01804049|
Recruitment Status : Completed
First Posted : March 5, 2013
Results First Posted : February 11, 2020
Last Update Posted : February 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prediabetes||Drug: metformin Drug: placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Metformin and Muscle in Insulin-resistant Older Veterans|
|Actual Study Start Date :||April 8, 2014|
|Actual Primary Completion Date :||August 31, 2018|
|Actual Study Completion Date :||August 31, 2018|
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
- Change in Total Lean Mass From Baseline [ Time Frame: 3 years ]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). The changes in appendicular and total lean mass were calculated by determining the change from baseline to the three year data point. If participants withdrew from the study prior to collection of 3 year data, the final time point available was used.
- Change in Physical Performance - 400 Meter Walk Speed [ Time Frame: 3 years ]At baseline, 1, 2, and 3 year follow-up visits, participants will have physical performance assessed using a 400 meter timed walk. We report the 400 meter timed walk speed as the change from baseline in seconds. The change in walk speed from baseline to the three year time point was used for analysis. For participants who withdrew from the study early, the walk speed from the final data point collected was used.
- Change in Muscle Characteristics [ Time Frame: 6 months ]At baseline and 6 month 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 histochemical and transcriptome analyses
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): NCT01804049
|United States, Oregon|
|VA Portland Health Care System, Portland, OR|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Robert F Klein||VA Portland Health Care System, Portland, OR|