Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
480 participants
INTERVENTIONAL
2009-05-31
2029-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Control group
Nutritional counselings every 6 months, no further intervention
No interventions assigned to this group
"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)
Multidisciplinary lifstyle intervention
Multidisciplinary lifstyle intervention (OPTIFAST®52-program)
Laparoscopic gastric sleeve intervention
Laparoscopic gastric sleeve
Laparoscopic gastric sleeve
Conventional bariatric surgery
Gastric Banding and Gastric Bypass
Gastric Banding
Gastric Banding
Roux-en-Y Bypass
Roux-en-Y Bypass
Interventions
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Laparoscopic gastric sleeve
Laparoscopic gastric sleeve
Gastric Banding
Gastric Banding
Multidisciplinary lifstyle intervention
Multidisciplinary lifstyle intervention (OPTIFAST®52-program)
Roux-en-Y Bypass
Roux-en-Y Bypass
Eligibility Criteria
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Inclusion Criteria
* 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
* Follow-up period \< 1 year or number of consultations within 3 years \< 3
18 Years
65 Years
ALL
No
Sponsors
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German Federal Ministry of Education and Research
OTHER_GOV
University of Hohenheim
OTHER
Responsible Party
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Principal Investigators
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Stephan C. Bischoff, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Hohenheim, Institute of Nutritional Medicine
Locations
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University of Heidelberg
Heidelberg, , Germany
University of Hohenheim
Stuttgart, , Germany
University of Tübingen
Tübingen, , Germany
Countries
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Central Contacts
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References
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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.
Damms-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.
Damms-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.
Damms-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.
Other Identifiers
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OGIT-FKZ01GI0843
Identifier Type: -
Identifier Source: org_study_id
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