MedDataX Logo

Leptin Signaling in Lean and Obese Humans

NCT ID: NCT01297426

Last Updated: 2015-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Lean and obese, diabetic and non diabetics

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christos Mantzoros, MD DSc

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ENDA-013-10F

Identifier Type: -

Identifier Source: org_study_id