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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Interleukin Genetics, Inc.
- Enrollment
- 824
- Locations
- 1
- Primary Endpoint
- Significant association of perilipin gene polymorphisms with obese subjects who are resistant to weight loss in a defined program.
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Significant association of perilipin gene polymorphisms with obese subjects who are resistant to weight loss in a defined program.
Time Frame: 6 months
Secondary Outcomes
- 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)