Leptin Receptors in the Bariatric Surgical Population Within the University of Pittsburgh Medical System: A Cohort Study

January 14, 2016 updated by: University of Pittsburgh

Prospective cohort study evaluating the role of leptin receptors in the bariatric surgical population compared with non obese controls. Additionally serum levels of leptin, ghrelin, motilin and PYY will be compared amongst the different BMI classes and a quality of life questionnaire completed by all participants.

The hypothesis is that obese individuals have lower leptin receptors in enterocytes which is partially responsible for the higher serum leptin levels without appropriate control of satiety.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

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
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh/UPMC Presby

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Males and Females undergoing endoscopy

Description

Inclusion Criteria:

  • Endoscopic Intervention

Exclusion Criteria:

  • 18 years of age or older
  • No acute GI bleeding

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

Cohorts and Interventions

Group / Cohort
Group 1: Control Group
BMI <30 There are 20 controls in this group
Group 2
BMI 30-35 There were 12 controls in this class
Group 3
BMI 35-40 There were 9 controls in this clas
Group 4
BMI >40 There were 9 controls in this class

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PCR test for Leptin Receptors
Time Frame: 1 week
Endoscopic biopsies of enterocytes will be measured via PCR
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ELISA test for ghrelin, motilin, leptin and PYY
Time Frame: 1 week
Blood samples collected to determine hormones via ELISA
1 week
IWQOL lite questionnaire
Time Frame: 1 week
Quality of Life questionnaire on obesity
1 week

Collaborators and Investigators

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

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Jennifer L Seminerio, MD, University of Pittsburgh

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

October 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimate)

March 21, 2014

Study Record Updates

Last Update Posted (Estimate)

January 15, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO13010529

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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