Changes in Cerebrospinal Fluid Biomarkers After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change in the levels of cerebrospinal fluid (CSF) proopiomelanocortin (POMC) derived peptides (fmol/ml) that occur in subjects after diet induced weight loss compared to RYGB and SG.
研究概览
简要总结
The goal of this project is to understand why bariatric surgery is such an effective treatment for obesity with a focus on brain mechanisms. Cerebrospinal fluid (CSF) neuropeptide, hormone and protein levels will be measured as a surrogate for changes in brain activity in participants before and after bariatric surgery as compared with participants before and after diet-induced weight loss. The investigators are studying neuropeptides and hormones that are know to be involved with the regulation of appetite and body weight to determine if some of the changes that are expected to occur after diet-induced weight loss do not occur after bariatric surgery. In addition, proteomic analysis will be used to uncover new protein biomarkers that are unique to surgical weight loss. The results of these studies will help explain why bariatric surgery is so effective in achieving long-term weight loss. Understanding how the central nervous system responds to bariatric surgery could help the development of alternative nonsurgical therapies for obesity and its metabolic complications.
详细描述
Peripheral metabolic signals communicate levels of energy stores to the brain and elicit a host of neuronal responses that maintain energy balance; such regulatory mechanisms make it difficult to maintain diet-induced weight loss. The goal is to understand how these central regulatory mechanisms are circumvented following surgical alterations in the gut in subjects after Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (SG) compared to carefully matched diet- induced weight loss controls who achieve weight loss on a low calorie liquid diet. Surgery participants will be patients who have already chosen to have a bariatric surgery procedure with their doctor. Diet participants will be provided with the low calorie liquid diet for approximately 3 months and will be monitored weekly throughout the study.
Surgery participants will be studied at 3 time-points:
- Before the intervention
- After surgery at 10-15% weight loss
- At 12 months after surgery
Low calorie diet participants will be studied at 2 time-points:
- Before intervention
- At 10-15% weight loss (approximately 12 weeks on the diet)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •18-65 years old
- •BMI 35-55
排除标准
- •No clinically significant medical conditions
- •No use of tobacco
- •No alcohol or drug abuse
- •No recent weight change (+/-5%) within prior 6 months
- •No medications that may affect body weight or blood glucose
- •No diabetes medications, beta-blockers, opiates or glucocorticoids
- •No pregnancy, breastfeeding, or planning to become pregnant during the study (diet group only)
- •No lactose intolerance
研究组 & 干预措施
Very Low Calorie Diet
干预措施: Very Low Calorie Diet (VLCD) (Behavioral)
Roux-en-Y Gastric Bypass Surgery
干预措施: Roux-en-Y Gastric Bypass (RYGB) (Procedure)
Sleeve Gastrectomy Surgery
干预措施: Sleeve Gastrectomy (SG) (Procedure)
结局指标
主要结局
Change in the levels of cerebrospinal fluid (CSF) proopiomelanocortin (POMC) derived peptides (fmol/ml) that occur in subjects after diet induced weight loss compared to RYGB and SG.
时间窗: Up to 12 months
POMC plays a critical role in regulating energy balance and levels decrease in the hypothalamus after diet-induced weight loss; this may lead to weight regain after dieting.
Comparison of changes in the CSF proteome that occur after diet-induced weight-loss compared to RYGB and SG using unbiased proteomic analysis.
时间窗: Up to 12 months
次要结局
- Comparison of the changes in Agouti-related protein (AgRP) concentrations (fmol/ml) in CSF and plasma that occur in subjects after diet induced weight loss compared to RYGB and SG.(Up to 12 months)
- Comparison of changes in CSF cortisol (ng/mL) that occur in subjects after diet induced weight loss compared to RYGB and SG.(Up to 12 months)
研究者
Sharon Wardlaw
Dr. Robert C. and Veronica Atkins Professor of Obesity Research
Columbia University