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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This study has been withdrawn prior to enrollment.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
  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 December 09, 2016