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RECRUITING
NCT01344525
NA

Pilot Project on Interdisciplinary Therapy of Obesity

Sponsor: University of Hohenheim

View on ClinicalTrials.gov

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.

Official title: Pilot Project on Interdisciplinary Therapy of Obesity and Its Consequences on Body Weight, Quality of Life and Gastrointestinal Parameters

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

480

Start Date

2009-05

Completion Date

2029-05

Last Updated

2018-10-26

Healthy Volunteers

No

Interventions

PROCEDURE

Laparoscopic gastric sleeve

Laparoscopic gastric sleeve

PROCEDURE

Gastric Banding

Gastric Banding

PROCEDURE

Multidisciplinary lifstyle intervention

Multidisciplinary lifstyle intervention (OPTIFAST®52-program)

PROCEDURE

Roux-en-Y Bypass

Roux-en-Y Bypass

Locations (3)

University of Heidelberg

Heidelberg, Germany

University of Hohenheim

Stuttgart, Germany

University of Tübingen

Tübingen, Germany