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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Nutritional counselings every 6 months, no further intervention | |
| "low-calorie-diet (LCD)"-based lifestyle intervention | Experimental | 12 months multidisciplinary weight loss program including three months low-calorie formula diet (800 kcal) (OPTIFAST®52 program) |
|
| Laparoscopic gastric sleeve intervention | Experimental |
| |
| Conventional bariatric surgery | Experimental | Gastric Banding and Gastric Bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic gastric sleeve | Procedure | Laparoscopic gastric sleeve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight loss | Every 6 months for a period of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | SF-36, IWQOL-lite | Every 6 months for a period of 3 years |
| Physical examination | Weight, height, waist circumference, blood pressure, bioelectric impedance analysis, pulse etc. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antje Damms-Machado, Dipl. troph. | Contact | +49 711 451017707 | antje.machado@uni-hohenheim.de | |
| Katrin Stingel, Dipl. troph. | Contact | +49 711 451017705 | k_stingel@uni-hohenheim.de |
| Name | Affiliation | Role |
|---|---|---|
| Stephan C. Bischoff, Prof. Dr. | University of Hohenheim, Institute of Nutritional Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Heidelberg | Recruiting | Heidelberg | 69120 | Germany | ||
| University of Hohenheim |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28049662 | Derived | 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. | |
| 25710027 | Derived |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000713 | Anastomosis, Roux-en-Y |
| ID | Term |
|---|---|
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |
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| Gastric Banding | Procedure | Gastric Banding |
|
| Multidisciplinary lifstyle intervention | Procedure | Multidisciplinary lifstyle intervention (OPTIFAST®52-program) |
|
| Roux-en-Y Bypass | Procedure | Roux-en-Y Bypass |
|
| Every 6 months for a period of 3 years |
| Laboratory analysis | Fasting glucose; Glutamat-Pyruvat- Transaminase (GPT); Lipid parameters (cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides) | Every 6 months for a period of 3 years |
| Vitamins/micronutrients | Vitamin B1, B6, B12, ß-carotene, niacin, folic acid, selen and oxidative metabolites | 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 |
| Liver fat | Liver sonography | Every 6 months for a period of 3 years |
| gut permeability | assessed by the uptake of inert molecules | Every 6 months for a period of 3 years |
| peripheral blood lipopolysaccharide concentrations | Every 6 months for a period of 3 years |
| Recruiting |
| Stuttgart |
| 70599 |
| Germany |
| University of Tübingen | Recruiting | Tübingen | 72076 | Germany |
| 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. |
| 22657586 | Derived | 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. |
| 22403000 | Derived | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |