Association of Genes to Resistance to Weight Loss in Obese Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00858221

Enrollment

824

Registered

2009-03-09

Start date

2008-08-31

Completion date

2009-07-31

Last updated

2009-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Metabolic Syndrome, Obesity

Keywords

obesity, genes, polymorphisms, weight loss, haplotype, diplotype

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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.	6 months

Countries

United States

Outcome results