NCT01344525Recruiting
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2018 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 480 (estimated)
- First submitted
- 27 Apr 2011
- Start date
- May 2009
- Primary completion date
- May 2029
- Lead sponsor
- University of Hohenheim
- Diseases
- Obesity
- NCT number
- NCT01344525
What you commit to
- Study type: Interventional
- Planned participants: 480
- From May 2009 to the primary completion date, May 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Body weight loss after intervention \< 10%
- Follow-up period \< 1 year or number of consultations within 3 years \< 3
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| University of Hohenheim Coordinator of this site? Confirm its status | Stuttgart | Germany | Recruiting |
| University of Tübingen Coordinator of this site? Confirm its status | Tübingen | Germany | Recruiting |
Related publications
- Baseline gut microbiome and metabolome profiles predict weight loss after a structured lifestyle intervention.Microbiome · 2026 · PMID 42668355
This page is information, not medical advice. Discuss any trial with your doctor.