Association of Genes to Resistance to Weight Loss in Obese Patients

NCT00858221 | Completed

• 1 other identifier: ILI-08-107PLIN
• Study Type: observational
• Target: 824
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Metabolic Syndrome; Dyslipidemia

Keywords

obesity; genes; polymorphisms; weight loss; haplotype; diplotype

Outcome Measures

Primary Outcomes (1)

• Significant association of perilipin gene polymorphisms with obese subjects who are resistant to weight loss in a defined program.

  6 months

Secondary Outcomes (1)

• 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

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Caucasian
• competent patients interested in Gastric Bypass Surgery
• patients who are eligible for Gastric Bypass Surgery based on NIH criteria:
• Male or Female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Interleukin Genetics, Inc.: lead

Study Sites (1)

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA to be analyzed by genotyping

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Dyslipidemias; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Lipid Metabolism Disorders; Body Weight Changes

Study Officials

• Karen Shaver, MS

  Interleukin Genetics

  STUDY DIRECTOR

• Christopher D. Still, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 9, 2009
• Study Start: August 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: July 1, 2009
• Last Updated: October 20, 2009

Record last verified: 2009-10

Locations

US (1)