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Pilot Project on Interdisciplinary Therapy of Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01344525
Recruitment Status : Recruiting
First Posted : April 29, 2011
Last Update Posted : October 26, 2018
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
University of Hohenheim

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Weight Loss Procedure: Laparoscopic gastric sleeve Procedure: Gastric Banding Procedure: Multidisciplinary lifstyle intervention Procedure: Roux-en-Y Bypass Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Project on Interdisciplinary Therapy of Obesity and Its Consequences on Body Weight, Quality of Life and Gastrointestinal Parameters
Study Start Date : May 2009
Estimated Primary Completion Date : May 2029
Estimated Study Completion Date : May 2029

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control group
Nutritional counselings every 6 months, no further intervention
Experimental: "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)
Procedure: Multidisciplinary lifstyle intervention
Multidisciplinary lifstyle intervention (OPTIFAST®52-program)

Experimental: Laparoscopic gastric sleeve intervention Procedure: Laparoscopic gastric sleeve
Laparoscopic gastric sleeve

Experimental: Conventional bariatric surgery
Gastric Banding and Gastric Bypass
Procedure: Gastric Banding
Gastric Banding

Procedure: Roux-en-Y Bypass
Roux-en-Y Bypass

Primary Outcome Measures :
  1. Body weight loss [ Time Frame: Every 6 months for a period of 3 years ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Every 6 months for a period of 3 years ]
    SF-36, IWQOL-lite

  2. Physical examination [ Time Frame: Every 6 months for a period of 3 years ]
    Weight, height, waist circumference, blood pressure, bioelectric impedance analysis, pulse etc.

  3. Laboratory analysis [ 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)

  4. Vitamins/micronutrients [ 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

  5. Metabolomics, and Microflora analysis [ Time Frame: Every 3-6 months for a period of maximal 3 years ]
  6. Liver fat [ Time Frame: Every 6 months for a period of 3 years ]
    Liver sonography

  7. gut permeability [ Time Frame: Every 6 months for a period of 3 years ]
    assessed by the uptake of inert molecules

  8. peripheral blood lipopolysaccharide concentrations [ Time Frame: Every 6 months for a period of 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01344525

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Contact: Antje Damms-Machado, Dipl. troph. +49 711 451017707
Contact: Katrin Stingel, Dipl. troph. +49 711 451017705

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University of Heidelberg Recruiting
Heidelberg, Germany, 69120
University of Hohenheim Recruiting
Stuttgart, Germany, 70599
University of Tübingen Recruiting
Tübingen, Germany, 72076
Sponsors and Collaborators
University of Hohenheim
German Federal Ministry of Education and Research
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Principal Investigator: Stephan C. Bischoff, Prof. Dr. University of Hohenheim, Institute of Nutritional Medicine
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Hohenheim Identifier: NCT01344525    
Other Study ID Numbers: OGIT-FKZ01GI0843
First Posted: April 29, 2011    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Keywords provided by University of Hohenheim:
obesity therapy
metabolic syndrome
gastrointestinal tract
Additional relevant MeSH terms:
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Weight Loss
Nutrition Disorders
Body Weight
Body Weight Changes