Metformin and Muscle in Insulin-resistant Older Veterans (M&M)
|ClinicalTrials.gov Identifier: NCT01804049|
Recruitment Status : Active, not recruiting
First Posted : March 5, 2013
Last Update Posted : January 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prediabetes||Drug: metformin Drug: placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated 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|
|Estimated Primary Completion Date :||August 31, 2018|
|Estimated 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 and appendicular lean mass [ 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).
- Change in physical performance [ Time Frame: 3 years ]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 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
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|