Leptin and Endothelial Function

Study Overview
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Brief Summary
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The purpose of this trial was to determine if injections of leptin would improve vascular function in normal-weight, healthy volunteers.

Detailed Description
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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 leptin 0.2 mg/kg SC, hereafter called rL, (Amgen Inc, Thousand Oaks, Calif) versus placebo SC (sorbitol and sodium acetate, pH 4.0 of same volume) in 15 non-obese adults. Subjects will have baseline vascular studies performed by brachial artery ultrasonography-flow-mediated dilatation and nitroglycerin mediated dilatation and blood drawn for measures of leptin levels. They will then receive rL SC or placebo SC (randomized order). They will then have vascular studies performed and blood levels drawn every 2 hours for 6 hours total. After completion of day 1, patients will return 1-4 weeks later and repeat the protocol crossed-over to the alternate intervention (rL or placebo).

Official Title
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The Role of Leptin in Modulating Vascular Tone and Endothelial Function in Obese and Normal Weight Adults: A Vascular-Protective Effect of Leptin?

Conditions
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Healthy

Intervention / Treatment
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* Drug: leptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female ages 18-50. BMI < 27 kg/m2 for lean group Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: leptin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow-mediated dilatation (FMD) of the brachial artery (conduit artery shear stress-mediated endothelial-dependent vasodilatation) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| basal brachial arterial diameter (BAD) (resting conduit artery tone) |  |  | 
| basal brachial arterial blood flow (BABF) (resting resistance artery tone) |  |  |