Association of Genes to Resistance to Weight Loss in Obese Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Body Weight Changes Dyslipidemia Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Geisinger Health System

Danville, Pennsylvania, 17822, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Interleukin Genetics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Mar 9, 2009
Registry last updated: Oct 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed