NCT01344525 Pilot Project on Interdisciplinary Therapy of Obesity
| NCT ID | NCT01344525 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Hohenheim |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2009-05 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 480 participants in total. It began in 2009-05 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Stephan C. Bischoff, Prof. Dr.
PRINCIPAL INVESTIGATOR
University of Hohenheim, Institute of Nutritional Medicine
Frequently Asked Questions
Who can join the NCT01344525 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01344525 currently recruiting?
Yes, NCT01344525 is actively recruiting participants. Contact the research team at antje.machado@uni-hohenheim.de for enrollment information.
Where is the NCT01344525 trial being conducted?
This trial is being conducted at Heidelberg, Germany, Stuttgart, Germany, Tübingen, Germany.
Who is sponsoring the NCT01344525 clinical trial?
NCT01344525 is sponsored by University of Hohenheim. The principal investigator is Stephan C. Bischoff, Prof. Dr. at University of Hohenheim, Institute of Nutritional Medicine. The trial plans to enroll 480 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.