Status:
COMPLETED
Metformin and Muscle in Insulin-resistant Older Veterans
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Oregon Health and Science University
Conditions:
Prediabetes
Eligibility:
All Genders
65+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 resista...
Detailed Description
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, fa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 8 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01804049
Start Date
April 8 2014
End Date
August 31 2018
Last Update
February 11 2020
Active Locations (1)
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1
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239