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Pilot Project on Interdisciplinary Therapy of Obesity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Hohenheim.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
University of Hohenheim
ClinicalTrials.gov Identifier:
NCT01344525
First received: April 27, 2011
Last updated: April 28, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention
Obesity
Weight Loss
 Procedure: Laparoscopic gastric sleeve
Procedure: Gastric Banding
Procedure: Multidisciplinary lifstyle intervention
Procedure: Roux-en-Y Bypass

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Hohenheim:

Primary Outcome Measures:
  • Body weight loss [ Time Frame: Every 6 months for a period of 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 480
Study Start Date: May 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344525

Contacts
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

Locations
Germany
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
Investigators
Principal Investigator: Stephan C. Bischoff, Prof. Dr. University of Hohenheim, Institute of Nutritional Medicine
  More Information

No publications provided by University of Hohenheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Stephan C. Bischoff, Univ.-Prof. Dr. med., University of Hohenheim, Institute of Nutritional Medicine
ClinicalTrials.gov Identifier: NCT01344525     History of Changes
Other Study ID Numbers: OGIT-FKZ01GI0843
Study First Received: April 27, 2011
Last Updated: April 28, 2011
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by University of Hohenheim:
obesity therapy
metabolic syndrome
gastrointestinal tract
microbiota
 metabolomics
micronutrients
outcome
sustainability

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 21, 2013