Pilot Project on Interdisciplinary Therapy of Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laparoscopic gastric sleeve, Gastric Banding, Multidisciplinary lifstyle intervention, Roux-en-Y Bypass.
- Who it may be relevant to
- Registry conditions: Obesity, Weight Loss. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Project on Interdisciplinary Therapy of Obesity and Its Consequences on Body Weight, Quality of Life and Gastrointestinal Parameters
Overview
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.
Detailed description
A database and a biomaterial bank will be established to assess, if the role of the gut for the development of obesity and obesity-related diseases such as fatty liver are of relevance in humans, e.g. for classification of afflicted individuals regarding risk or outcome after intervention. During 3 years, the investigators will include 480 obese individuals (4 cohorts of 120 individuals) who undergo a treatment program (either surgical or non-surgical), and follow them up for at least 3 years. Every 6 months, a visit is planned at the obesity center where the initial intervention has been performed. Within the visits, anthropometry (Body Mass Index (BMI), excess body weight (EBW), bioelectrical impedance analysis (BIA)), quality of life (SF36 score, Impact Of Weight On Quality Of Life (IWQOL) questionnaire), and sample collection for laboratory analyses (inflammatory markers, hormones, flora composition, micronutrients, metabolomics etc.) will be performed. Patients will be recruited from 3 centers in Germany. The long-term expectation from this model project is to find gastrointestinal parameters allowing to predict outcome and sustainability of different intervention strategies. In addition, intervention programs will be compared regarding long-term outcome and quality of life changes.
Interventions
- Procedure Laparoscopic gastric sleeve
Laparoscopic gastric sleeve - Procedure Gastric Banding
Gastric Banding - Procedure Multidisciplinary lifstyle intervention
Multidisciplinary lifstyle intervention (OPTIFAST®52-program) - Procedure Roux-en-Y Bypass
Roux-en-Y Bypass
Primary outcome measures
- Body weight loss [Time frame: Every 6 months for a period of 3 years]
Secondary outcome measures (8)
- Quality of life [Time frame: Every 6 months for a period of 3 years]
- Physical examination [Time frame: Every 6 months for a period of 3 years]
- Laboratory analysis [Time frame: Every 6 months for a period of 3 years]
- Vitamins/micronutrients [Time frame: Every 3-6 months for a period of maximal 3 years]
- Metabolomics, and Microflora analysis [Time frame: Every 3-6 months for a period of maximal 3 years]
- Liver fat [Time frame: Every 6 months for a period of 3 years]
- gut permeability [Time frame: Every 6 months for a period of 3 years]
- peripheral blood lipopolysaccharide concentrations [Time frame: Every 6 months for a period of 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 3 centers
- University of Heidelberg — Heidelberg
- University of Hohenheim — Stuttgart
- University of Tübingen — Tübingen
Publications
- 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 28049662
- 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. PMID 25710027
- 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. PMID 22657586
- 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. PMID 22403000
Identifiers
NCT: NCT01344525 · OGIT-FKZ01GI0843