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Pilot Project on Interdisciplinary Therapy of Obesity

RecruitingNAAges 18 Years - 65 YearsAllUniversity of Hohenheim
NCT01344525 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Laparoscopic gastric sleeve
  • Gastric Banding
  • Multidisciplinary lifstyle intervention
  • Roux-en-Y Bypass
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Where

3 sites
University of Heidelberg
Heidelberg, Germany
University of Hohenheim
Stuttgart, Germany
University of Tübingen
Tübingen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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