Pilot Project on Interdisciplinary Therapy of Obesity

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Weight Loss

Intervention / Treatment
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* Procedure: Laparoscopic gastric sleeve
* Procedure: Gastric Banding
* Procedure: Multidisciplinary lifstyle intervention
* Procedure: Roux-en-Y Bypass


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Nutritional counselings every 6 months, no further intervention | |
| Experimental: low-calorie-diet (LCD)-based lifestyle intervention<br>12 months multidisciplinary weight loss program including three months low-calorie formula diet (800 kcal) (OPTIFAST®52 program) | Procedure: Multidisciplinary lifstyle intervention<br>* Multidisciplinary lifstyle intervention (OPTIFAST®52-program)<br>|
| Experimental: Laparoscopic gastric sleeve intervention<br> | Procedure: Laparoscopic gastric sleeve<br>* Laparoscopic gastric sleeve<br>|
| Experimental: Conventional bariatric surgery<br>Gastric Banding and Gastric Bypass | Procedure: Gastric Banding<br>* Gastric Banding<br>Procedure: Roux-en-Y Bypass<br>* Roux-en-Y Bypass<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight loss |  | Every 6 months for a period of 3 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity therapy, metabolic syndrome, gastrointestinal tract, microbiota, metabolomics, micronutrients, outcome, sustainability