Effects of Metformin in a Non-Diabetic Patient Population

• Status: Completed
• Trial end date: 2020-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Metformin has a well-established safety profile and it has become clear that metformin has additional salutary effects, including anti-inflammatory, anti-aging, and anti-thrombotic properties. In this study, subjects will provide both venous blood samples and stool samples in addition to completing cognitive and physiologic testing at baseline, throughout a 90 day exposure to metformin, and 30 days following exposure to metformin in order to evaluate their immune, microbiome, cellular respiration, thrombotic, and inflammatory responses.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brian Zuckerbraun
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. Age ≥55 and ≤85 years of age

2. Non-diabetic

3. Adjusted risk analysis index (RAI) 20-42

4. Estimated glomerular filtration rate >45

5. No evidence of hepatic dysfunction on comprehensive metabolic panel

6. No clinical evidence of cardiac failure

7. Existing University of Pittsburgh Medical Center Patients

Exclusion Criteria:

1. Hypersensitivity to metformin or any component of the formulation

2. Acute or chronic metabolic acidosis with or without coma

3. Pregnant or breastfeeding females

4. Evidence or history of hepatic, renal, or cardiopulmonary failure

5. Excessive acute or chronic ethanol use

6. Planned or known hospital admission, exposure to anesthesia, or surgical intervention 30 days prior to study or scheduled 30 days after the trial initiation

7. Laboratory analysis showing HbgA1c >6.1 or eGFR <44 on baseline labs