Pharmacokinetics of Leptin Administration During Fasting

NCT00140205 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-11-02

Study results available
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Summary

The purpose of this study will be to determine the correct dose of leptin, a natural hormone secreted by the fat cells, to give to people when they are fasting and also to determine whether giving leptin to a person when he or she is fasting will reverse the changes in hormone levels that occur with fasting.

Conditions

  • Energy Deficiency Due to Short-term Fasting

Interventions

DRUG

r-metHuLeptin

r-metreleptin was given in 3 different dose in fed and fasting states

Sponsors & Collaborators

Principal Investigators

  • Christos S Mantzoros, MD DSc FACP FACE · Beth Israel Deaconess Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-02-28
Primary Completion
2004-06-30
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00140205 on ClinicalTrials.gov