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Leptin and Endothelial Function

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ClinicalTrials.gov Identifier: NCT00121433
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : June 27, 2006
Sponsor:
Collaborator:
Amgen
Information provided by:
University of Michigan

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

Condition or disease Intervention/treatment Phase
Healthy Drug: leptin Phase 4

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  (Clinical Trial)
Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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?
Study Start Date : September 2004
Study Completion Date : December 2004



Primary Outcome Measures :
  1. flow-mediated dilatation (FMD) of the brachial artery (conduit artery shear stress-mediated endothelial-dependent vasodilatation)

Secondary Outcome Measures :
  1. basal brachial arterial diameter (BAD) (resting conduit artery tone)
  2. basal brachial arterial blood flow (BABF) (resting resistance artery tone)


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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)

ClinicalTrials.gov Identifier: NCT00121433     History of Changes
Other Study ID Numbers: GCRC 1955
GCRC 1955
IRB 2003-0383
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: June 27, 2006
Last Verified: July 2005