Characterization of Physiological Mechanisms Involved in the Regulation of Eating Behavior for the Identification of Innovative Nutritional Strategies for Obese Patients Before and After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Modifications of Endocannabinoid and N-acylethanolamine plasma levels
研究概览
简要总结
The aim of the study is to evaluate modifications in the metabolism of polyunsaturated fatty acids (PUFA) and biosynthesis of the lipid mediators N-acylethanolamines (NAE), both known to induce and be induced by the nuclear peroxisome proliferator-activated receptor (PPAR)-α, which may also explain the well-established improved lipid and energy metabolism after bariatric surgery. The study is focused on understanding the weight loss mechanisms in order to develop targeted dietary protocols.
详细描述
The study involves a careful preliminary medical history of the patients, with physical examination, anthropometric parameters measurements and blood sampling for blood chemistry routine and evaluation of any adverse events to assess suitability for the study. The evening before bariatric surgery, one month and six months after bariatric surgery anthropometric parameters measurements, blood sampling for blood chemistry routine, inflammatory and lipid-metabolomic profile, and evaluation of any adverse events are performed. For the study samples are stored identified by a code to be analyzed anonymously. Study interruption criteria are: development of allergic reactions, ketonemia> 1.5 mmol/L, acute gout
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects with pathological obesity suitable for bariatric surgery
- •Body Mass Index (BMI) range 35-59
排除标准
- •established diagnoses of a major disease (e.g., diabetes or kidney disease)
- •pregnancy or breastfeeding,
- •food allergies,
- •use of drugs that could affect lipid metabolism
结局指标
主要结局
Modifications of Endocannabinoid and N-acylethanolamine plasma levels
时间窗: 6 months
These lipid derivatives are involved in control of energy expenditure and lipid metabolism and are measured by LC MS/MS and expressed as nmol/ml plasma
Weight loss as kg, and fat mass reduction as total kg and percent of body mass
时间窗: 6 months
Indicators of the success of the intervention
Changes in fatty acid plasma profile induced by bariatric surgery
时间窗: 6 months
Fatty acid profile affect lipid derivatives. Fatty acid are measured by LC and GC and expressed as nmol/ml plasma
次要结局
未报告次要终点
研究者
Sebastiano Banni
Full Professor
University of Cagliari