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临床试验/NCT01344525
NCT01344525招募中不适用

Pilot Project on Interdisciplinary Therapy of Obesity and Its Consequences on Body Weight, Quality of Life and Gastrointestinal Parameters

University of Hohenheim3 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2009年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
480
试验地点
3
主要终点
Body weight loss

研究概览

简要总结

Obese individuals that undergo major intervention such as a low-calorie formula diet program or bariatric surgery with the result of substantial weight loss (> 10%) are included and followed-up for at least 3 years. Weight changes and excess weight loss as well as measures of quality of life are monitored. In addition, biomaterials will be collected from these individuals every 6 months for measurement of parameters related to obesity-associated gastrointestinal (GI) impairments such as change in GI hormone levels, change in GI microbiota, or enhanced bacterial translocation. Moreover, micronutrient and metabolomics analysis will be performed. This project allows comparison of non-surgical and surgical intervention and enables to asses the anticipated relationship between obesity and the GI tract in humans in the future.

详细描述

A database and a biomaterial bank will be established to assess, if the role of the gut for the development of obesity and obesity-related diseases such as fatty liver are of relevance in humans, e.g. for classification of afflicted individuals regarding risk or outcome after intervention. During 3 years, the investigators will include 480 obese individuals (4 cohorts of 120 individuals) who undergo a treatment program (either surgical or non-surgical), and follow them up for at least 3 years. Every 6 months, a visit is planned at the obesity center where the initial intervention has been performed. Within the visits, anthropometry (Body Mass Index (BMI), excess body weight (EBW), bioelectrical impedance analysis (BIA)), quality of life (SF36 score, Impact Of Weight On Quality Of Life (IWQOL) questionnaire), and sample collection for laboratory analyses (inflammatory markers, hormones, flora composition, micronutrients, metabolomics etc.) will be performed. Patients will be recruited from 3 centers in Germany. The long-term expectation from this model project is to find gastrointestinal parameters allowing to predict outcome and sustainability of different intervention strategies. In addition, intervention programs will be compared regarding long-term outcome and quality of life changes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
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

入选标准

  • Adults (18-65 years at time of inclusion)
  • Obesity defined as BMI > 30 kg/m2
  • Obesity treatment (multidisciplinary life style intervention with LCD or bariatric surgery) resulting in an estimated body weight loss of >10% of the initial body weight within 6 month

排除标准

  • Body weight loss after intervention < 10%
  • Follow-up period < 1 year or number of consultations within 3 years < 3

研究组 & 干预措施

Control group

No Intervention

Nutritional counselings every 6 months, no further intervention

"low-calorie-diet (LCD)"-based lifestyle intervention

Experimental

12 months multidisciplinary weight loss program including three months low-calorie formula diet (800 kcal) (OPTIFAST®52 program)

干预措施: Multidisciplinary lifstyle intervention (Procedure)

Laparoscopic gastric sleeve intervention

Experimental

干预措施: Laparoscopic gastric sleeve (Procedure)

Conventional bariatric surgery

Experimental

Gastric Banding and Gastric Bypass

干预措施: Gastric Banding (Procedure)

Conventional bariatric surgery

Experimental

Gastric Banding and Gastric Bypass

干预措施: Roux-en-Y Bypass (Procedure)

结局指标

主要结局

Body weight loss

时间窗: Every 6 months for a period of 3 years

次要结局

  • gut permeability(Every 6 months for a period of 3 years)
  • Physical examination(Every 6 months for a period of 3 years)
  • peripheral blood lipopolysaccharide concentrations(Every 6 months for a period of 3 years)
  • Laboratory analysis(Every 6 months for a period of 3 years)
  • Liver fat(Every 6 months for a period of 3 years)
  • Quality of life(Every 6 months for a period of 3 years)
  • Vitamins/micronutrients(Every 3-6 months for a period of maximal 3 years)
  • Metabolomics, and Microflora analysis(Every 3-6 months for a period of maximal 3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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