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临床试验/NCT05775172
NCT05775172已完成不适用

Gastric Myoelectric Activity, Inflammatory, Dietary, and Body Composition Changes During Weight Loss Via Bariatric Surgery and Lifestyle Modification

King Saud University1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
79
试验地点
1
主要终点
Gastric myoelectric activity

研究概览

简要总结

Gastric myoelectric, inflammatory, and hormonal responses, body compositional, energy expenditure, and metabolic changes during the development of obesity and the weight loss process are underinvestigated. This project studied the myoelectrical inflammatory and hormonal responses of the stomach, in addition to energy expenditure and body composition changes during weight loss via bariatric surgery and lifestyle intervention.

详细描述

Gastric myoelectric, inflammatory, and hormonal responses, body compositional, energy expenditure, and metabolic changes during the development of obesity and the weight loss process are underinvestigated. This project studied the myoelectrical, inflammatory, and hormonal responses of the stomach, in addition to energy expenditure and body composition changes during weight loss via bariatric surgery and lifestyle intervention.

Methods: We recruited 79 participants who were assigned to three groups: bariatric surgery (BS group n=27), lifestyle intervention (LS group, n=22), and waitlist control (C group n=30). For all participants, electrogastrography, inflammatory cytokines, gastric hormones analysis, body composition analysis, energy expenditure, and dietary assessment were done at baseline and at 6 months.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI > 35 kg/m2,
  • Being free of any acute medical condition, inflammatory conditions, malignancy, or psychiatric disorders

排除标准

  • Taking weight-losing pharmacotherapy
  • Who underwent previous bariatric surgery

结局指标

主要结局

Gastric myoelectric activity

时间窗: 6 months

The gastric myoelectric activity was measured in fasting (for 10 mins) and post-prandial state (for 30 mins) using a multichannel electrogastrography (EGG) with a water load satiety test

Resting Energy Expenditure

时间窗: 6 MONTHS

Resting metabolic rate (RMR) was measured by the automated metabolic cart indirect calorimetry (IC) using a standard canopy hood

Body composition measurement

时间窗: 6 MONTHS

Body composition was analyzed via a multi-Frequency segmental bioelectric impedance analysis monitor

Inflammatory changes

时间窗: 6 months

Serum levels of inflammatory markers involving interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and monocyte chemoattractant protein (MCP-1),

hormonal analysis

时间窗: 6 Months

serum levels of ghrelin, gastrin, and irisin (ELISA kits MyBiosource, San Diego, CA, USA; Catalog numbers: MBS2700428, MBS264399, MBS2600406, respectively).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Abulmeaty, M.D., FACN.

Professor

King Saud University

研究点 (1)

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