NCT01344525

Pilot Project on Interdisciplinary Therapy of Obesity

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: University of Hohenheim · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Obesity
• Weight Loss

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic gastric sleeve	Laparoscopic gastric sleeve
PROCEDURE	Gastric Banding	Gastric Banding
PROCEDURE	Multidisciplinary lifstyle intervention	Multidisciplinary lifstyle intervention (OPTIFAST®52-program)
PROCEDURE	Roux-en-Y Bypass	Roux-en-Y Bypass

Timeline

• Start date: 2009-05-01
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2011-04-29
• Last updated: 2018-10-26

Locations

3 sites across 1 country: Germany