Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Leptin Signaling in Lean and Obese Humans (Leptin signali)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Department of Veterans Affairs Identifier:
First received: February 14, 2011
Last updated: February 18, 2015
Last verified: February 2015

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

Further study details as provided by Department of Veterans Affairs:

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

Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
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.


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

diabetic or nondiabetic lean and obese subjects


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 identifier: NCT01297426

United States, Massachusetts
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Principal Investigator: Christos Mantzoros, MD DSc VA Medical Center, Jamaica Plain Campus
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs Identifier: NCT01297426     History of Changes
Other Study ID Numbers: ENDA-013-10F
Study First Received: February 14, 2011
Last Updated: February 18, 2015
Health Authority: United States: Federal Government processed this record on March 02, 2015