Role of Metformin on Muscle Health of Older Adults

• Status: Recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

Muscle atrophy and insulin resistance are common after bed rest in healthy older adults. Metformin treatment has been shown to improve insulin sensitivity and attenuate muscle loss in insulin resistance adults though the mechanisms are not fully known. Metformin used as a preventive strategy to maintain muscle and metabolic health in bed ridden older adults has not been investigated.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Utah
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Age 60y and older

• Ability to sign informed consent

• Free-living, prior to admission

Exclusion Criteria:

• Personal history of cardiovascular disease

• Uncontrolled endocrine or metabolic disease (e.g., hypo/hyperthyroidism, HbA1c ≥6.5%)

• Evidence of kidney disease or failure (defined as serum creatinine > 1.5mg/dL)

• Vascular disease or risk factors of peripheral atherosclerosis. (e.g., uncontrolled hypertension, obesity, diabetes)

• Risk of Deep vein thrombosis including family history of thrombophilia, Deep vein thrombosis, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb>18 g/dL) or thrombocytosis (platelets>400x103/mL)

• Use of anticoagulant therapy (e.g., Coumadin, heparin)

• Uncontrolled hypertension (e.g. systolic pressure >160 or a diastolic blood pressure > 100)

• Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma

• Currently on a weight-loss diet or body mass index > 30 kg/m2

• Inability to abstain from smoking for duration of study

• HIV or hepatitis B or C*

• Subjects excluded due to positive screening results, including HIV, hepatitis B or hepatitis C, will be immediately scheduled for counseling and follow-up testing as needed, and will be advised to consult their primary physician.

• 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 are permitted). Androgens or growth hormone within 6 months of enrollment and for study duration (topical physiologic androgen replacement is permitted)

• Subjects with hemoglobin or hematocrit lower than accepted lab values

• History of stroke with motor disability

• A recent history (<12 months) of GI bleed

• Depression [>5 on the 15 items Geriatric Depression Scale (GDS)]*

*This criteria will only apply to subjects in the bed rest arm.

• Liver disease (the ratio of serum aspartate aminotransferase to serum alanine aminotransferase 2 times above the normal limit, hyperbilirubinemia) History of respiratory disease

• Currently taking estrogen products (topical vaginal products are not exclusionary (e.g. cream))

• Recent travel history as defined by 4 hours of travel by airplane in the last week

• Any other condition or event considered exclusionary by the PI and faculty physician