Pilot Project on Interdisciplinary Therapy of Obesity

Recruiting now · Not applicable

Conditions studied: Obesity, Weight Loss

In brief

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.

Key facts

Study ID: NCT01344525
Run by: University of Hohenheim
People needed: 480
Starts: 2009-05-01
Expected to finish: 2029-05-01
Last updated by the study team: 2018-10-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of Heidelberg — Heidelberg, Germany (enrolling)
University of Hohenheim — Stuttgart, Germany (enrolling)
University of Tübingen — Tübingen, Germany (enrolling)

Full record on ClinicalTrials.gov

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