MedTrace Logo

Role of Leptin in the Neuroendocrine and Immune Response to Fasting

NCT00140231 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-06-07

Study results available
· View outcomes & findings →

Summary

The purpose of this study will be to determine whether giving leptin (r-metHuLeptin) to a person when he or she is fasting will reverse changes in metabolism, and hormone levels, and immune function associated with fasting, which decreases leptin levels.

Conditions

  • Fasting

Interventions

DRUG

r-metHuLeptin

recombinant human leptin

OTHER

placebo

placebo (no active drug)

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Amgen

    collaborator INDUSTRY

  • Beth Israel Deaconess Medical Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2011-03-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT00140231 on ClinicalTrials.gov