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
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Pennsylvania
-
Danville、Pennsylvania、美国、17822
- Geisinger Health System
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Significant association of perilipin gene polymorphisms with obese subjects who are resistant to weight loss in a defined program.
大体时间：6 months
|
6 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
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.
大体时间：6 months
|
6 months
|
合作者和调查者
调查人员
- 研究主任：Karen Shaver, MS、Interleukin Genetics
- 首席研究员：Christopher D. Still, MD、Geisinger Clinic
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.