This trial is active, not recruiting.

Conditions obesity, weight loss
Treatments laparoscopic gastric sleeve, gastric banding, multidisciplinary lifstyle intervention, roux-en-y bypass
Sponsor University of Hohenheim
Collaborator German Federal Ministry of Education and Research
Start date May 2009
End date May 2018
Trial size 480 participants
Trial identifier NCT01344525, OGIT-FKZ01GI0843


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model factorial assignment
Masking open label
Primary purpose treatment
(No Intervention)
Nutritional counselings every 6 months, no further intervention
12 months multidisciplinary weight loss program including three months low-calorie formula diet (800 kcal) (OPTIFAST®52 program)
multidisciplinary lifstyle intervention
Multidisciplinary lifstyle intervention (OPTIFAST®52-program)
laparoscopic gastric sleeve
Laparoscopic gastric sleeve
Gastric Banding and Gastric Bypass
gastric banding
Gastric Banding
roux-en-y bypass
Roux-en-Y Bypass

Primary Outcomes

Body weight loss
time frame: Every 6 months for a period of 3 years

Secondary Outcomes

Quality of life
time frame: Every 6 months for a period of 3 years
Physical examination
time frame: Every 6 months for a period of 3 years
Laboratory analysis
time frame: Every 6 months for a period of 3 years
time frame: Every 3-6 months for a period of maximal 3 years
Metabolomics, and Microflora analysis
time frame: Every 3-6 months for a period of maximal 3 years
Liver fat
time frame: Every 6 months for a period of 3 years
gut permeability
time frame: Every 6 months for a period of 3 years
peripheral blood lipopolysaccharide concentrations
time frame: Every 6 months for a period of 3 years

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Pilot Project on Interdisciplinary Therapy of Obesity and Its Consequences on Body Weight, Quality of Life and Gastrointestinal Parameters
Principal investigator Stephan C. Bischoff, Prof. Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Hohenheim.