Pilot Project on Interdisciplinary Therapy of Obesity
Recruiting · NCT01344525 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Hohenheim
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
3 locations listed.
- University of Heidelberg - Heidelberg, Germany
- University of Hohenheim - Stuttgart, Germany
- University of Tübingen - Tübingen, Germany