Association of Genes to Resistance to Weight Loss in Obese Patients

October 19, 2009 updated by: Interleukin Genetics, Inc.

Association of Genetic Variants in Obesity Genes to Resistance to Weight Loss and Susceptibility to Metabolic Syndrome in Morbidly Obese Patients: A Single Center, Blinded, Retrospective Clinical Study

The overall goal of this study is to determine whether variations in the perilipin, and several other, genes would be a useful tool for physicians who are caring for morbidly obese patients to guide therapy.

The main hypotheses to be tested is that sequence variations (polymorphisms) in the perilipin gene and several other obesity-related genes are associated with resistance to weight loss for obese individuals on energy restricted diets, potentially playing a role in the development of obesity related complications.

Study Overview

Status

Completed

Conditions

Detailed Description

The PRIMARY goal of this study is to investigate the association of perilipin gene polymorphisms, with obese subjects who are "resistant" to weight loss in a defined program.

The SECONDARY goal of this study is to investigate if additional candidate obesity genes that have previously been associated with obesity or energy metabolism show association with resistance to weight loss in subjects on an energy restricted diet. Additionally, we would like to investigate if any metabolic syndrome parameters, such as dyslipidemia or abnormal fasting glucose are associated with perilipin or variations in other obesity-related genes.

Study Type

Observational

Enrollment (Actual)

824

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
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Health System

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

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Caucasian adults between the age of 21 and 70 years, inclusive, who fit the criteria for patients undergoing bariatric surgery at the Geisinger Clinic.

Description

Inclusion Criteria:

  • Caucasian
  • competent patients interested in Gastric Bypass Surgery

  • patients who are eligible for Gastric Bypass Surgery based on NIH criteria:

    • Male or Female
    • 21 - 70 years old, inclusive
    • Body Mass Index (BMI) > 40 with 2 co-morbid conditions such as Sleep Apnea, Hypertension, or Type 2 Diabetes
    • BMI > 45 with no co-morbid conditions

Exclusion Criteria:

  • Patients not interested in Gastric Bypass Surgery
  • Patients who do not qualify for surgery based on medical contraindications
  • Patients with severe psychological contraindications
  • Patients not willing to be compliant with pre-post surgical recommendations
  • Patients younger than 21 years of age
  • Patients older than 70 years of age
  • Patients who do not qualify for surgery based on insurance constraints i.e., insurance guidelines for bypass surgery
  • Patients who are pregnant
  • Hispanic, Black, Asian Races
  • Abnormal thyroid function

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Significant association of perilipin gene polymorphisms with obese subjects who are resistant to weight loss in a defined program.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Significant association of other genes, known to be obesity-related, with resistance to weight loss. Also, association of primary and secondary gene SNPs with dyslipidemia.
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Interleukin Genetics, Inc.

Investigators

  • Study Director: Karen Shaver, MS, Interleukin Genetics
  • Principal Investigator: Christopher D. Still, MD, Geisinger Clinic

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

August 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 6, 2009

First Posted (Estimate)

March 9, 2009

Study Record Updates

Last Update Posted (Estimate)

October 20, 2009

Last Update Submitted That Met QC Criteria

October 19, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILI-08-107PLIN

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.

Clinical Trials on Obesity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe