Leptin and Endothelial Function - Full Text View

Sponsors and Collaborators:	University of Michigan Amgen
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00121433

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: leptin	Phase IV

Drug Information available for: Leptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study
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?

Further study details as provided by University of Michigan:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	15
Study Start Date:	September 2004
Estimated Study Completion Date:	December 2004

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).

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	GCRC 1955, GCRC 1955, IRB 2003-0383
Study First Received:	July 13, 2005
Last Updated:	June 23, 2006
ClinicalTrials.gov Identifier:	NCT00121433
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Body Weight
Obesity
Healthy

ClinicalTrials.gov processed this record on January 15, 2009