Leptin Signaling in Lean and Obese Humans (Leptin signali)

This study has been withdrawn prior to enrollment.

(funding expired)

Sponsor:

Information provided by (Responsible Party):

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT01297426

First received: February 14, 2011

Last updated: December 23, 2015

Last verified: December 2015

History of Changes

Purpose

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.

Condition
Obesity


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Cross-Sectional
Official Title:	Leptin Signaling in Humans

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:

Westerns / activation of signaling pathways (uo to two hours after treatment) [ Time Frame: 04/01/2016 ] [ Designated as safety issue: No ]


Enrollment:	0
Study Start Date:	April 2011
Study Completion Date:	June 2015
Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts
Group 1 Lean and obese, diabetic and non diabetics

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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

diabetic or nondiabetic lean and obese subjects

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297426

Locations


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

Sponsors and Collaborators

VA Office of Research and Development

Investigators


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

More Information


Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT01297426 History of Changes
Other Study ID Numbers:	ENDA-013-10F
Study First Received:	February 14, 2011
Last Updated:	December 23, 2015
Health Authority:	United States: Federal Government

ClinicalTrials.gov processed this record on September 27, 2016

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