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?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00121433

Enrollment

Registered

2005-07-21

Start date

2004-09-30

Completion date

2004-12-31

Last updated

2006-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

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).

Interventions

DRUGleptin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026