Leptin and Endothelial Function

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: leptin

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 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).

• Study Type: Interventional
• Enrollment: 15
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
basal brachial arterial diameter (BAD) (resting conduit artery tone)
basal brachial arterial blood flow (BABF) (resting resistance artery tone)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Amgen

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Study Completion: December 1, 2004

Study Registration Dates

• First Submitted: July 13, 2005
• First Submitted That Met QC Criteria: July 19, 2005
• First Posted (Estimate): July 21, 2005

Study Record Updates

• Last Update Posted (Estimate): June 27, 2006
• Last Update Submitted That Met QC Criteria: June 23, 2006
• Last Verified: July 1, 2005

More Information

Terms related to this study

• Other Study ID Numbers: GCRC 1955; IRB 2003-0383