Association of Genes to Resistance to Weight Loss in Obese Patients

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858221
• Other study ID #: ILI-08-107PLIN
• Status: Completed
• Phase: N/A
• First received: March 5, 2009
• Last updated: October 19, 2009
• Start date: August 2008
• Est. completion date: July 2009

Study information

• Verified date: October 2009
• Source: Interleukin Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 824
• Est. completion date: July 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Weight Loss

Locations

Country	Name	City	State
United States	Geisinger Health System	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Interleukin Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant association of perilipin gene polymorphisms with obese subjects who are resistant to weight loss in a defined program.		6 months	No
Secondary	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	No