Association of Genes to Resistance to Weight Loss in Obese Patients

Completed

• Conditions: Metabolic Syndrome; Dyslipidemia; Obesity

• Registration Number: NCT00858221
• Lead Sponsor: Interleukin Genetics, Inc.

Brief Summary

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.

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 Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-06
• Study First Posted: 2009-03-09
• Primary Completion: 2009-04
• Study Completion: 2009-07
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-19
• Last Update Posted: 2009-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 824

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Significant association of perilipin gene polymorphisms with obese subjects who are resistant to weight loss in a defined program.	6 months

Secondary Outcome Measures

Name	Time	Method
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.	6 months

Trial Locations

Locations (1)

Geisinger Health System; 🇺🇸 Danville, Pennsylvania, United States