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
University of Hohenheim
480 participants
May 1, 2009
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria2
- Body weight loss after intervention < 10%
- Follow-up period < 1 year or number of consultations within 3 years < 3
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Interventions
Laparoscopic gastric sleeve
Gastric Banding
Multidisciplinary lifstyle intervention (OPTIFAST®52-program)
Roux-en-Y Bypass
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT01344525