PILOT STUDY: The Metabolic and Genetic Drivers of Body Composition Changes Following Weight Loss Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Body composition
研究概览
简要总结
Weight loss surgery is very good at reducing body weight but it can also cause the loss of both muscle and strength. Some patients undergoing weight loss surgery do not achieve their weight loss goals and regain the weight they lost. When this occurs, the loss of muscle and strength combined with the regain of weight can impact the individual's quality of life and ability to remain active and mobile.
The purpose of this study is to understand the behavioral, biological, and genetic factors that influence the success of weight loss surgery and its impact on muscle mass.
Bariatric surgery patients participating in the trial will be monitored prior to, and for a year following weight loss surgery, with data collected about their eating habits, hand grip strength, and the loss of fat, muscle, and body weight following surgery. In patients who undergo a routine endoscopy in advance of weight loss surgery a small sample of gut tissue will be collected to identify the expression (activity) of genes in their DNA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(Bariatric Surgery Patients):
- •Age: 18 to 65 years at time of consent
- •BMI: 35-65 kg.m-2
- •Scheduled to undergo bariatric surgery at UTMB
- •All races and ethnic backgrounds
- •Ability to speak and read English
- •Subject has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures.
排除标准
- •(Bariatric Surgery Patients):
- •Fails the medical criteria for bariatric surgery.
- •Anemia (hematocrit < 33 % or donated blood in the past 12 weeks.)
- •Recent (5 years or less) history of cancer
- •Systemic steroids or immunosuppressant use for 8 or more consecutive days in the past 6 months, or any use of anabolic steroids or growth hormones in the same period.
- •Body mass index < 35 or > 65 kg.m-
- •Acute infectious disease or chronic infection.
- •Pregnancy or breast-feeding.
- •Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.
- •History of prior non-compliance that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigator's instructions.
- •Concurrent participation in another research study.
- •Use of an investigational agent in the 30 days prior to signing informed consent.
研究组 & 干预措施
Bariatric Surgery Patients
Patients due to undergo either sleeve gastrectomy or gastric bypass surgery.
Healthy Control Subjects
Healthy weight individuals recruited from the local population.
结局指标
主要结局
Body composition
时间窗: Measured at baseline in both healthy volunteers & bariatric surgery patients undergoing metabolic assessment. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.
Body composition will be determined in patients by whole-body bioelectrical impedance. Regional body composition will be additionally assessed in healthy volunteers and bariatric surgery patients undergoing metabolic assessment via whole-body dual-energy x-ray absorptiometry (DXA) imaging. Procedures will be performed on a single occasion in healthy volunteers and up to three times in bariatric patients undergoing metabolic assessment.
Whole-body Protein Turnover Rates
时间窗: Measured at baseline in both healthy volunteers & patients undergoing metabolic assessment. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.
Whole-body protein turnover rates measured over a 48 hour period, accomplished via the consumption of a drink containing isotopically labelled (15N) alanine and the subsequent collection of urine for two days. Will be performed on a single occasion in healthy volunteers and up to three times in bariatric patients undergoing metabolic assessment.
Association between foregut gene expression and degree of weight reduction
时间窗: A single occasion from tissue collected during the routine pre-operative upper endoscopy. (baseline)
Assessed only in patients. Gene expression of the foregut will be analyzed in tissue collected from patients during the routine pre-operative upper endoscopy. Subsequently, participants will be stratified into those achieving: \<10%, 10-20%, or \>20% weight loss 12 months post-surgery, and differentially expressed genes between the three groups determined.
次要结局
- Association between foregut gene expression and degree of weight reduction(A single occasion from tissue collected during the routine pre-operative upper endoscopy. (baseline))
- Dietary Protein Intake(Measured at baseline in both healthy volunteers & patients undergoing metabolic assessment. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.)
- Body weight(Measured at baseline in both healthy volunteers & bariatric surgery patients. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.)
- Body composition(Measured at baseline in both healthy volunteers & bariatric surgery patients undergoing metabolic assessment. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.)
- Short Physical Performance Battery Test(Measured at baseline in both healthy volunteers & bariatric surgery patients. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.)
- Handgrip Strength(Measured at baseline in both healthy volunteers & bariatric surgery patients. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.)
- Physical Activity levels (accelerometry)(Measured at baseline in both healthy volunteers & bariatric surgery patients. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.)
- Energy Intake(Measured at baseline in both healthy volunteers & bariatric surgery patients undergoing metabolic assessment. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.)
- Energy Expenditure(Measured at baseline in both healthy volunteers & bariatric surgery patients undergoing metabolic assessment. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.)