Laparoscopic gastric sleeve
ProcedureLaparoscopic gastric sleeve
NCT Number: NCT01344525
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
University of Heidelberg, Heidelberg, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laparoscopic gastric sleeve
Gastric Banding
Multidisciplinary lifstyle intervention (OPTIFAST®52-program)
Roux-en-Y Bypass
Time frame: Every 6 months for a period of 3 years
Time frame: Every 6 months for a period of 3 years
SF-36, IWQOL-lite
Time frame: Every 6 months for a period of 3 years
Weight, height, waist circumference, blood pressure, bioelectric impedance analysis, pulse etc.
Time frame: Every 6 months for a period of 3 years
Fasting glucose; Glutamat-Pyruvat- Transaminase (GPT); Lipid parameters (cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides)
Time frame: Every 3-6 months for a period of maximal 3 years
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
Time frame: Every 6 months for a period of 3 years
Liver sonography
Time frame: Every 6 months for a period of 3 years
assessed by the uptake of inert molecules
Time frame: Every 6 months for a period of 3 years
Contact information is provided by the study sponsor or research team.
Antje Damms-Machado, Dipl. troph.
CONTACT
Katrin Stingel, Dipl. troph.
CONTACT
University of Hohenheim
Other
Pilot Project on Interdisciplinary Therapy of Obesity and Its Consequences on Body Weight, Quality of Life and Gastrointestinal Parameters
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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