Association of Genes to Resistance to Weight Loss in Obese Patients

NCT ID: NCT00858221

Last Updated: 2009-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

824 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-07-31

Brief Summary

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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

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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.

Conditions

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Obesity Metabolic Syndrome Dyslipidemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Interleukin Genetics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Interleukin Genetics, Inc.

Principal Investigators

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Karen Shaver, MS

Role: STUDY_DIRECTOR

Interleukin Genetics

Christopher D. Still, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

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Geisinger Health System

Danville, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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ILI-08-107PLIN

Identifier Type: -

Identifier Source: org_study_id

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