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Metformin and Muscle in Insulin-resistant Older Veterans (M&M)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01804049
First Posted: March 5, 2013
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
VA Office of Research and Development
February 28, 2013
March 5, 2013
August 14, 2017
April 8, 2014
August 31, 2018   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01804049 on ClinicalTrials.gov Archive Site
  • 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
  • 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 histologic characteristics [ Time Frame: 1 year ]
    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.
Not Provided
Not Provided
 
Metformin and Muscle in Insulin-resistant Older Veterans
Metformin and Muscle in Insulin-resistant Older Veterans
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.
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. The investigators' 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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Prediabetes
  • Drug: 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
  • Drug: placebo
    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.
  • Placebo Comparator: Placebo
    60 participants will be randomized to placebo pills.
    Intervention: Drug: placebo
  • Active Comparator: Metformin
    60 enrolled participants will be randomized to metformin.
    Intervention: Drug: metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
August 31, 2018
August 31, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • The investigators will enroll 120 sedentary, weight-stable, ambulatory Veterans aged 65 years and older with prediabetes identified with fasting glucose values 100 mg/dL or greater but under 126 mg/dL with no use of diabetes medications.
  • Participants must demonstrate that they are able to ambulate 400 meters without assistance.

Exclusion Criteria:

  • Chronic medical conditions affecting muscle mass or function like active non-skin cancer and hypogonadism
  • Medications affecting muscle mass or function like glucocorticoids and androgen/antiandrogens
  • Contraindications to metformin such as renal dysfunction defined as creatinine >= 1.5 mg/dL for men or >=1.4 mg/dL for women or eGFR<60 mL/min; liver dysfunction defined as ALT>48 U/L, AST>41 U/L or AlkPhos>141U/L; B12 deficiency defined as B12 level <180 pg/dL; congestive heart failure; known hypersensitivity to metformin; excessive alcohol intake (average of 2 or more alcoholic beverages/day over a month)

For the muscle biopsy substudy, additional exclusion criteria include:

  • Conditions that include bleeding risk such as the use of warfarin, clopidogrel/ticlopidine, aggrenox, dabigatran or anagrelide; laboratory results showing platelets<150 billion/L or INR>1.2 or aPTT>36 seconds
  • Allergy to lidocaine
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01804049
CLIN-019-12S
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: No
VA Office of Research and Development
VA Office of Research and Development
Oregon Health and Science University
Principal Investigator: Robert F Klein VA Portland Health Care System, Portland, OR
VA Office of Research and Development
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP