Pilot Project on Interdisciplinary Therapy of Obesity

Not Applicable

Recruiting

• Conditions: Obesity; Weight Loss
• Interventions: Procedure: Multidisciplinary lifstyle intervention; Procedure: Laparoscopic gastric sleeve; Procedure: Gastric Banding; Procedure: Roux-en-Y Bypass

• Registration Number: NCT01344525
• Lead Sponsor: University of Hohenheim

Brief 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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-26
• Primary Completion: 2029-05
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
"low-calorie-diet (LCD)"-based lifestyle intervention	Multidisciplinary lifstyle intervention	12 months multidisciplinary weight loss program including three months low-calorie formula diet (800 kcal) (OPTIFAST®52 program)
Conventional bariatric surgery	Roux-en-Y Bypass	Gastric Banding and Gastric Bypass
Laparoscopic gastric sleeve intervention	Laparoscopic gastric sleeve	-
Conventional bariatric surgery	Gastric Banding	Gastric Banding and Gastric Bypass

Primary Outcome Measures

Name	Time	Method
Body weight loss	Every 6 months for a period of 3 years

Secondary Outcome Measures

Name	Time	Method
Physical examination	Every 6 months for a period of 3 years	Weight, height, waist circumference, blood pressure, bioelectric impedance analysis, pulse etc.
peripheral blood lipopolysaccharide concentrations	Every 6 months for a period of 3 years
Laboratory analysis	Every 6 months for a period of 3 years	Fasting glucose; Glutamat-Pyruvat- Transaminase (GPT); Lipid parameters (cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides)
Liver fat	Every 6 months for a period of 3 years	Liver sonography
Quality of life	Every 6 months for a period of 3 years	SF-36, IWQOL-lite
Vitamins/micronutrients	Every 3-6 months for a period of maximal 3 years	Vitamin B1, B6, B12, ß-carotene, niacin, folic acid, selen and oxidative metabolites
gut permeability	Every 6 months for a period of 3 years	assessed by the uptake of inert molecules
Metabolomics, and Microflora analysis	Every 3-6 months for a period of maximal 3 years

Trial Locations

Locations (3)

University of Tübingen; 🇩🇪 Tübingen, Germany

University of Hohenheim; 🇩🇪 Stuttgart, Germany

University of Heidelberg; 🇩🇪 Heidelberg, Germany