Metformin, Muscle Energetics, and Vascular Function in Older Adults With Peripheral Artery Disease

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators are doing this research study to find out if taking Metformin improves walking ability in patients with peripheral arterial disease (PAD). In PAD the arteries (blood vessels) in the legs are narrowed because of the build up of plaque. The leg muscle can hurt in patients with PAD and this is usually described as a cramp or tiredness. This pain is called intermittent claudication. Metformin is an FDA approved medication for the treatment of diabetes. The investigators believe that Metformin may help your leg muscles work better.

The investigators will enroll up to 100 subjects in order to find 60 subjects with PAD at Brigham and Women's Hospital (BWH).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Age 40 years or greater

• Intermittent claudication for 6 months or greater

• Maximal walk time between 1-20 minutes on all ETTs

• Resting ABI ≤ 0.9 in index leg at baseline

• ABI falls ≥ 20% in index leg 1 minute post baseline ETT

• MWT variability < 20%

Exclusion Criteria:

• Type 1 or Type 2 Diabetes

• Limb-threatening ischemia (rest pain, ulceration, gangrene)

• Peripheral vascular surgery or PCI within 6 months

• MI or CABG within 6 months

• Carotid endarterectomy (CEA) within 6 months

• Cerebrovascular accident or TIA within 6 months

• Uncontrolled hypertension (SBP > 140 mmHg, DBP >90 mmHg)

• Pentoxifylline/Cilostazol added/changed within 3 months

• HMG-CoA reductase inhibitor added/changed within 3 months

• Exercise limitations other than claudication (heart failure, angina, COPD, arthritis, neuropathy, etc.)

• Serum creatinine ≥ 1.5 mg/dL

• Pregnant or plans to become pregnant

• 2 hour Oral Glucose Tolerance Test (OGTT) > 200 mg/dL