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New treatment option for Muscle Atrophy or Weakness
Official title Metformin and Muscle Recovery
ClinicalTrials.gov ID: NCT06185179
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for muscle atrophy or weakness.
Also referred to as Glucophage, Fortamet.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- Use of anticoagulant therapy (e.g., Coumadin, heparin)
See the full eligibility criteria
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.