Pilot Project on Interdisciplinary Therapy of Obesity
1 other identifier
interventional
480
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started May 2009
Longer than P75 for not_applicable obesity
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 27, 2011
CompletedFirst Posted
Study publicly available on registry
April 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
October 26, 2018
October 1, 2018
20 years
April 27, 2011
October 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body weight loss
Every 6 months for a period of 3 years
Secondary Outcomes (8)
Quality of life
Every 6 months for a period of 3 years
Physical examination
Every 6 months for a period of 3 years
Laboratory analysis
Every 6 months for a period of 3 years
Vitamins/micronutrients
Every 3-6 months for a period of maximal 3 years
Metabolomics, and Microflora analysis
Every 3-6 months for a period of maximal 3 years
- +3 more secondary outcomes
Study Arms (4)
Control group
NO INTERVENTIONNutritional counselings every 6 months, no further intervention
"low-calorie-diet (LCD)"-based lifestyle intervention
EXPERIMENTAL12 months multidisciplinary weight loss program including three months low-calorie formula diet (800 kcal) (OPTIFAST®52 program)
Laparoscopic gastric sleeve intervention
EXPERIMENTALConventional bariatric surgery
EXPERIMENTALGastric Banding and Gastric Bypass
Interventions
Laparoscopic gastric sleeve
Multidisciplinary lifstyle intervention (OPTIFAST®52-program)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Body weight loss after intervention \< 10%
- Follow-up period \< 1 year or number of consultations within 3 years \< 3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Heidelberg
Heidelberg, 69120, Germany
University of Hohenheim
Stuttgart, 70599, Germany
University of Tübingen
Tübingen, 72076, Germany
Related Publications (4)
Damms-Machado A, Louis S, Schnitzer A, Volynets V, Rings A, Basrai M, Bischoff SC. Gut permeability is related to body weight, fatty liver disease, and insulin resistance in obese individuals undergoing weight reduction. Am J Clin Nutr. 2017 Jan;105(1):127-135. doi: 10.3945/ajcn.116.131110. Epub 2016 Nov 9.
PMID: 28049662DERIVEDDamms-Machado A, Mitra S, Schollenberger AE, Kramer KM, Meile T, Konigsrainer A, Huson DH, Bischoff SC. Effects of surgical and dietary weight loss therapy for obesity on gut microbiota composition and nutrient absorption. Biomed Res Int. 2015;2015:806248. doi: 10.1155/2015/806248. Epub 2015 Feb 1.
PMID: 25710027DERIVEDDamms-Machado A, Weser G, Bischoff SC. Micronutrient deficiency in obese subjects undergoing low calorie diet. Nutr J. 2012 Jun 1;11:34. doi: 10.1186/1475-2891-11-34.
PMID: 22657586DERIVEDDamms-Machado A, Friedrich A, Kramer KM, Stingel K, Meile T, Kuper MA, Konigsrainer A, Bischoff SC. Pre- and postoperative nutritional deficiencies in obese patients undergoing laparoscopic sleeve gastrectomy. Obes Surg. 2012 Jun;22(6):881-9. doi: 10.1007/s11695-012-0609-0.
PMID: 22403000DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan C. Bischoff, Prof. Dr.
University of Hohenheim, Institute of Nutritional Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2011
First Posted
April 29, 2011
Study Start
May 1, 2009
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
May 1, 2029
Last Updated
October 26, 2018
Record last verified: 2018-10