Status:
COMPLETED
Leptin and Endothelial Function
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Amgen
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
The purpose of this trial was to determine if injections of leptin would improve vascular function in normal-weight, healthy volunteers.
Detailed Description
The researchers plan to enroll a total of 15 non-obese (BMI \< 27 kg/m2) otherwise healthy adults into a randomized, double-blinded, cross-over study of the impact of recombinant methionyl human lepti...
Eligibility Criteria
Inclusion
- Healthy male or female ages 18-50.
- BMI \< 27 kg/m2 for lean group
Exclusion
- Any CVD risk factor (diabetes or fasting glucose \> 126 mg/dL
- Hypertension or measured BP \> 140/90 mmHg
- Current tobacco smoking within last month
- LDL\>160 mg/dL, HDL\<35 mg/dL)
- Renal insufficiency (creatinine \> 1.4 mg/dL)
- Thyroid abnormalities (abnormal TSH)
- Established CVD (any atherosclerosis, or history of peripheral arterial disease, previous stroke, myocardial infarction, angina, heart failure, aortic aneurysms)
- Usage of medications which impact endothelial function within last month (folate, fish oil, Vitamin C or E, L-arginine, blood pressure or lipid-lowering medications, diabetes medications)
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00121433
Start Date
September 1 2004
End Date
December 1 2004
Last Update
June 27 2006
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