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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Notify MeKey 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
Primary outcomes
-
flow-mediated dilatation (FMD) of the brachial artery (conduit artery shear stress-mediated endothelial-dependent vasodilatation)
Secondary outcomes
-
basal brachial arterial diameter (BAD) (resting conduit artery tone)
-
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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