Status:
TERMINATED
Metformin, Muscle Energetics, and Vascular Function in Older Adults With Peripheral Artery Disease
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Peripheral artery disease (PAD) is a manifestation of atherosclerosis that affects more than 7 million adults in the US. The prevalence of PAD increases with age and is estimated to be 15 20% among in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01901224
Start Date
July 1 2013
End Date
June 1 2015
Last Update
September 24 2018
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115