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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
University of Heidelberg
RECRUITING
Heidelberg
University of Hohenheim
RECRUITING
Stuttgart
University of Tübingen
RECRUITING
Tübingen
Contact Information
Primary
Antje Damms-Machado, Dipl. troph.
antje.machado@uni-hohenheim.de
+49 711 451017707
Backup
Katrin Stingel, Dipl. troph.
k_stingel@uni-hohenheim.de
+49 711 451017705
Time Frame
Start Date: 2009-05
Estimated Completion Date: 2029-05
Participants
Target number of participants: 480
Treatments
No_intervention: Control group
Nutritional counselings every 6 months, no further intervention
Experimental: low-calorie-diet (LCD)-based lifestyle intervention
12 months multidisciplinary weight loss program including three months low-calorie formula diet (800 kcal) (OPTIFAST®52 program)
Experimental: Laparoscopic gastric sleeve intervention
Experimental: Conventional bariatric surgery
Gastric Banding and Gastric Bypass
Related Therapeutic Areas
Sponsors
Leads: University of Hohenheim
Collaborators: German Federal Ministry of Education and Research

This content was sourced from clinicaltrials.gov