Clinical trial

Pilot Project on Interdisciplinary Therapy of Obesity

Recruiting now · Not applicable · 1 countries · Registry ID NCT01344525

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Weight Loss

Full registry criteria

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

Treatments and study arms

Laparoscopic gastric sleeve

Procedure

Laparoscopic gastric sleeve

Gastric Banding

Procedure

Gastric Banding

Multidisciplinary lifstyle intervention

Procedure

Multidisciplinary lifstyle intervention (OPTIFAST®52-program)

Roux-en-Y Bypass

Procedure

Roux-en-Y Bypass

Primary outcomes

Body weight lossEvery 6 months for a period of 3 years

Study locations

3 locations were listed when this page was built. The first 40 are shown.

University of Heidelberg🇩🇪 Heidelberg, Germany

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University of Hohenheim🇩🇪 Stuttgart, Germany

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University of Tübingen🇩🇪 Tübingen, Germany

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