An interventional study of Laparoscopic gastric sleeve and Gastric Banding in Obesity and Weight Loss, sponsored by University of Hohenheim. Recruiting at 3 sites in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-26.
Sponsored by University of Hohenheim · Not applicable, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 480 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Hohenheim is the lead sponsor of 43 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nutritional counselings every 6 months, no further intervention
12 months multidisciplinary weight loss program including three months low-calorie formula diet (800 kcal) (OPTIFAST®52 program)
Procedure: Multidisciplinary lifstyle intervention
Procedure: Laparoscopic gastric sleeve
Gastric Banding and Gastric Bypass
Procedure: Gastric Banding · Procedure: Roux-en-Y Bypass
Laparoscopic gastric sleeve
Gastric Banding
Multidisciplinary lifstyle intervention (OPTIFAST®52-program)
Roux-en-Y Bypass
Body weight loss
Time frame: Every 6 months for a period of 3 years
Quality of life
SF-36, IWQOL-lite
Time frame: Every 6 months for a period of 3 years
Physical examination
Weight, height, waist circumference, blood pressure, bioelectric impedance analysis, pulse etc.
Time frame: 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)
Time frame: Every 6 months for a period of 3 years
Vitamins/micronutrients
Vitamin B1, B6, B12, ß-carotene, niacin, folic acid, selen and oxidative metabolites
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
Liver sonography
Time frame: Every 6 months for a period of 3 years
gut permeability
assessed by the uptake of inert molecules
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
The record gives a start of May 2009, a primary completion of May 2029 and a completion of May 2029. It does not say whether these dates are actual or estimated.
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University of Hohenheim