Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pilot Project on Interdisciplinary Therapy of Obesity

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
University of Hohenheim
ClinicalTrials.gov Identifier:
NCT01344525
First received: April 27, 2011
Last updated: February 17, 2015
Last verified: February 2015

April 27, 2011
February 17, 2015
May 2009
December 2015   (final data collection date for primary outcome measure)
Body weight loss [ Time Frame: Every 6 months for a period of 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01344525 on ClinicalTrials.gov Archive Site
  • Quality of life [ Time Frame: Every 6 months for a period of 3 years ] [ Designated as safety issue: No ]
    SF-36, IWQOL-lite
  • Physical examination [ Time Frame: Every 6 months for a period of 3 years ] [ Designated as safety issue: No ]
    Weight, height, waist circumference, blood pressure, bioelectric impedance analysis, pulse etc.
  • Laboratory analysis [ Time Frame: Every 6 months for a period of 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Liver fat [ Time Frame: Every 6 months for a period of 3 years ] [ Designated as safety issue: No ]
    Liver sonography
Same as current
Not Provided
Not Provided
 
Pilot Project on Interdisciplinary Therapy of Obesity
Pilot Project on Interdisciplinary Therapy of Obesity and Its Consequences on Body Weight, Quality of Life and Gastrointestinal Parameters

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Weight Loss
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
480
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01344525
OGIT-FKZ01GI0843
Not Provided
University of Hohenheim
University of Hohenheim
German Federal Ministry of Education and Research
Principal Investigator: Stephan C. Bischoff, Prof. Dr. University of Hohenheim, Institute of Nutritional Medicine
University of Hohenheim
February 2015

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