NCT06185179 Metformin and Muscle Recovery
| NCT ID | NCT06185179 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Utah |
| Condition | Muscle Atrophy or Weakness |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2029-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2024-09-01 with a primary completion date of 2029-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 of independence. Mechanistic-based therapeutic strategies to enhance muscle recovery in older adults do not exist. Metformin has been implicated to have positive effects on muscle size and function through non-glycemic mechanisms. Metformin has been shown to enhance macrophage function and lessen cellular senescence burden by targeting SASP in a variety of muscle interstitial cells. However, the role of metformin to improve muscle recovery in older adults following disuse atrophy through immunomodulating and senomorphic mechanisms have not been examined. Therefore, the purpose of this study is to conduct a randomized, double blind, placebo-controlled clinical trial in older adult participants to determine if short-term metformin delivery (vs placebo) during the recovery phase following disuse atrophy can improve muscle regrowth.
Eligibility Criteria
Inclusion Criteria: 1. Age between 60y and older 2. BMI: \<30 kg/m2 3. Good general medical health, ambulatory and in independent living setting 4. Adequate upper body strength to use assistive walking device (crutches, walker, etc) as assessed by PI/staff during screening 5. Clinical Frailty Scale score \< 3 6. Mini-Cog score \> 3 Exclusion Criteria: 1. History of cardiovascular disease (e.g., CHF, CAD, MI, CVA) 2. History of endocrine or metabolic disease such as hypo/hyperthyroidism and diabetes (Treated hypo/hyperthyroid for at least 6 months will be permitted) 3. History of kidney disease or failure (CKD \> stage 4; serum creatinine \>1.5mg/dL) 4. History of vascular disease 5. 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 6. Use of anticoagulant therapy (e.g., Coumadin, heparin) 7. Uncontrolled hypertension - Elevated systolic pressure \>150 or a diastolic blood pressure \> 100 8. Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators) 9. Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma 10. 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) 11. Androgens or growth hormone within 6 months of enrollment and for study duration (topical physiologic androgen replacement will be permitted) 12. Inability to abstain from smoking or vaping for duration of study 13. Currently taking estrogen products (topical estrogen products will be permitted) 14. Currently on weight loss diet or medication 15. History of stroke with motor disability 16. A recent history (\<12 months) of GI bleed 17. History of liver disease or AST/ALT 2 times above the normal limit 18. History of respiratory disease (acute upper respiratory infection, history of chronic lung disease) 19. Any staff members who report directly to the principal investigators
Contact & Investigator
Micah Drummond
PRINCIPAL INVESTIGATOR
University of Utah
Frequently Asked Questions
Who can join the NCT06185179 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Muscle Atrophy or Weakness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06185179 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06185179 currently recruiting?
Yes, NCT06185179 is actively recruiting participants. Contact the research team at micah.drummond@hsc.utah.edu for enrollment information.
Where is the NCT06185179 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT06185179 clinical trial?
NCT06185179 is sponsored by University of Utah. The principal investigator is Micah Drummond at University of Utah. The trial plans to enroll 50 participants.