Metformin and Muscle in Insulin-resistant Older Veterans

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Prediabetes

In brief

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.

Key facts

Study ID

NCT01804049

Run by

VA Office of Research and Development

People needed

120

Starts

2014-04-08

Expected to finish

2018-08-31

Last updated by the study team

2020-02-11

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 estimated glomerular filtration rate (eGFR)<60 mL/min; liver dysfunction defined as alanine aminotransferase (ALT)>48 U/L, aspart aminotransferase (AST)>41 U/L or alkaline phosphatase (AlkPhos)>141 U/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 international normalized ratio (INR)>1.2 or activated partial thromboplastin time (aPTT)>36 seconds
• Allergy to lidocaine

Where it is running

• VA Portland Health Care System, Portland, OR — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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