Leptin Signaling in Lean and Obese Humans (Leptin signali)

December 23, 2015 updated by: VA Office of Research and Development

Leptin Signaling in Humans

Obesity does not respond to high circulating levels of the hormone leptin. This study is aiming at finding out why this happens and open new avenues for treatment of obesity.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

Ex vivo and in vitro identification and study of leptin signaling pathways in commercially available cell lines serum/ plasma samples and discarded tissues from humans.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

diabetic or nondiabetic lean and obese subjects

Description

Inclusion Criteria:

  • men and women
  • ages 18 to 65
  • BMI ranges between 20 and 45 kg/m2

Exclusion Criteria:

  • subjects requiring special diets
  • history of illness other than obesity of diabetes
  • taking medications known to influence glucose metabolism
  • subjects with history of anaphylactic reaction or hypersensitivity to e. coli derived proteins or anesthetic agents
  • women who are breastfeeding, pregnant or wanting to become pregnant
  • subjects with bleeding dyscrasia or poor wound healing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Group 1
Lean and obese, diabetic and non diabetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Westerns / activation of signaling pathways (uo to two hours after treatment)
Time Frame: 04/01/2016
04/01/2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Christos Mantzoros, MD DSc, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 15, 2011

First Posted (Estimate)

February 16, 2011

Study Record Updates

Last Update Posted (Estimate)

December 24, 2015

Last Update Submitted That Met QC Criteria

December 23, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • ENDA-013-10F

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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