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Leptin and Endothelial Function

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00121433
First received: July 13, 2005
Last updated: June 23, 2006
Last verified: July 2005
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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?

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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

ClinicalTrials.gov processed this record on November 24, 2014