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Pilot Project on Interdisciplinary Therapy of Obesity

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ClinicalTrials.gov Identifier: NCT01344525
Recruitment Status : Recruiting
First Posted : April 29, 2011
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
University of Hohenheim

Tracking Information
First Submitted Date  ICMJE April 27, 2011
First Posted Date  ICMJE April 29, 2011
Last Update Posted Date October 26, 2018
Study Start Date  ICMJE May 2009
Estimated Primary Completion Date May 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2011)
Body weight loss [ Time Frame: Every 6 months for a period of 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2016)
  • Quality of life [ Time Frame: Every 6 months for a period of 3 years ]
    SF-36, IWQOL-lite
  • Physical examination [ Time Frame: Every 6 months for a period of 3 years ]
    Weight, height, waist circumference, blood pressure, bioelectric impedance analysis, pulse etc.
  • 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)
  • 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
  • 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 ]
    Liver sonography
  • gut permeability [ Time Frame: Every 6 months for a period of 3 years ]
    assessed by the uptake of inert molecules
  • peripheral blood lipopolysaccharide concentrations [ Time Frame: Every 6 months for a period of 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2011)
  • Quality of life [ Time Frame: Every 6 months for a period of 3 years ]
    SF-36, IWQOL-lite
  • Physical examination [ Time Frame: Every 6 months for a period of 3 years ]
    Weight, height, waist circumference, blood pressure, bioelectric impedance analysis, pulse etc.
  • 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)
  • 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
  • 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 ]
    Liver sonography
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Project on Interdisciplinary Therapy of Obesity
Official Title  ICMJE Pilot Project on Interdisciplinary Therapy of Obesity and Its Consequences on Body Weight, Quality of Life and Gastrointestinal Parameters
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Weight Loss
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
    Intervention: Procedure: Multidisciplinary lifstyle intervention
  • Experimental: Laparoscopic gastric sleeve intervention
    Intervention: Procedure: Laparoscopic gastric sleeve
  • Experimental: Conventional bariatric surgery
    Gastric Banding and Gastric Bypass
    Interventions:
    • Procedure: Gastric Banding
    • Procedure: Roux-en-Y Bypass
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 28, 2011)
480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2029
Estimated Primary Completion Date May 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Antje Damms-Machado, Dipl. troph. +49 711 451017707 antje.machado@uni-hohenheim.de
Contact: Katrin Stingel, Dipl. troph. +49 711 451017705 k_stingel@uni-hohenheim.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01344525
Other Study ID Numbers  ICMJE OGIT-FKZ01GI0843
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Hohenheim
Study Sponsor  ICMJE University of Hohenheim
Collaborators  ICMJE German Federal Ministry of Education and Research
Investigators  ICMJE
Principal Investigator: Stephan C. Bischoff, Prof. Dr. University of Hohenheim, Institute of Nutritional Medicine
PRS Account University of Hohenheim
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP