Leptin and Endothelial Function
The purpose of this trial was to determine if injections of leptin would improve vascular function in normal-weight, healthy volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||The Role of Leptin in Modulating Vascular Tone and Endothelial Function in Obese and Normal Weight Adults: A Vascular-Protective Effect of Leptin?|
- flow-mediated dilatation (FMD) of the brachial artery (conduit artery shear stress-mediated endothelial-dependent vasodilatation)
- basal brachial arterial diameter (BAD) (resting conduit artery tone)
- basal brachial arterial blood flow (BABF) (resting resistance artery tone)
|Study Start Date:||September 2004|
|Estimated Study Completion Date:||December 2004|
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).