Effect of Metformin on Frailty in 12 Subjects

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will test whether chronic metformin administration will improve longevity of the cell, improves its machinery by reducing aging-related biochemical parameters and thereby improving physical performance, as measured by short physical performance battery test.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Age ≥ 60 years

• Stable CAD

• Prediabetes (one of the following criteria should be met)

• Fasting plasma glucose: 100-126 mg/dL

• HbA1C: 5.7-6.4

• Frailty (Short Physical Performance Battery: Score <9)

• Able to return for follow-up

• Written informed consent

Exclusion criteria:

• Pre-existing or new-onset diabetes

• Any active malignancy, hematological disorder, post organ transplant, immunocompromised

• Cancer requiring treatment in the past 3 years (other than non-melanoma skin cancer)

• Dementia [mini mental state examination (MMSE <20)]

• Disability (need for assistance in >2 of any six activities on Katz activities of daily living (ADL)46

• Prior stroke with disability

• Acute coronary syndrome <3months or participating in cardiac rehabilitation

• Severe Parkinson's

• Hepatic insufficiency and/or chronic liver disease (cirrhosis)

• Chronic kidney disease (GFR < 45 mL/min)

• Taking metformin for any indication

• Acute alcohol intoxication

• Known hypersensitivity to metformin hydrochloride

• Acute/chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma