Status:
RECRUITING
Metformin and Muscle Recovery
Lead Sponsor:
University of Utah
Conditions:
Muscle Atrophy or Weakness
Eligibility:
All Genders
60+ years
Phase:
EARLY_PHASE1
Brief Summary
A hallmark of aging is an impaired ability to adequately recover following a stressor, such as muscle disuse, resulting in muscle fibrosis and weakness thereby increasing the risk for falls and loss o...
Detailed Description
Aging is associated with impaired muscle recovery following disuse atrophy. If not addressed, restricted muscle regrowth and function may lead to a cascade of health crisis events for the aged individ...
Eligibility Criteria
Inclusion
- Age between 60y and older
- BMI: \<30 kg/m2
- Good general medical health, ambulatory and in independent living setting
- Adequate upper body strength to use assistive walking device (crutches, walker, etc) as assessed by PI/staff during screening
- Clinical Frailty Scale score \< 3
- Mini-Cog score \> 3
Exclusion
- History of cardiovascular disease (e.g., CHF, CAD, MI, CVA)
- History of endocrine or metabolic disease such as hypo/hyperthyroidism and diabetes (Treated hypo/hyperthyroid for at least 6 months will be permitted)
- History of kidney disease or failure (CKD \> stage 4; serum creatinine \>1.5mg/dL)
- History of vascular disease
- Risk of DVT including family history of thrombophilia, DVT, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb\>18 g/dL) or thrombocytosis (platelets\>400x103/mL), and connective tissue diseases (positive lupus anticoagulant), hyperhomocystinemia, deficiencies of factor V Leiden, proteins S and C, and antithrombine III
- Use of anticoagulant therapy (e.g., Coumadin, heparin)
- Uncontrolled hypertension - Elevated systolic pressure \>150 or a diastolic blood pressure \> 100
- Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
- Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma
- Chronic systemic corticosteroid use (≥ 2 weeks) within 4 weeks of enrollment and for study duration (intra-articular/topical/inhaled therapeutic or physiologic doses of corticosteroids will be permitted)
- Androgens or growth hormone within 6 months of enrollment and for study duration (topical physiologic androgen replacement will be permitted)
- Inability to abstain from smoking or vaping for duration of study
- Currently taking estrogen products (topical estrogen products will be permitted)
- Currently on weight loss diet or medication
- History of stroke with motor disability
- A recent history (\<12 months) of GI bleed
- History of liver disease or AST/ALT 2 times above the normal limit
- History of respiratory disease (acute upper respiratory infection, history of chronic lung disease)
- Any staff members who report directly to the principal investigators
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2030
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06185179
Start Date
September 1 2024
End Date
May 31 2030
Last Update
December 5 2025
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84112