NCT00121433

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4 healthy

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_4 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
Last Updated

June 27, 2006

Status Verified

July 1, 2005

First QC Date

July 13, 2005

Last Update Submit

June 23, 2006

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • basal brachial arterial diameter (BAD) (resting conduit artery tone)

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

Interventions

leptinDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female ages 18-50.
  • BMI \< 27 kg/m2 for lean group

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Leptin

Intervention Hierarchy (Ancestors)

AdipokinesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2005

First Posted

July 21, 2005

Study Start

September 1, 2004

Study Completion

December 1, 2004

Last Updated

June 27, 2006

Record last verified: 2005-07