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OpenTrials
Completed

NCT Number: NCT00121433

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Leptin

Drug

Primary outcomes

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

Secondary outcomes

  1. basal brachial arterial diameter (BAD) (resting conduit artery tone)

  2. basal brachial arterial blood flow (BABF) (resting resistance artery tone)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Amgen

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2004
First posted
Jul 21, 2005
Registry last updated
Jun 27, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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