Pilot Project on Interdisciplinary Therapy of Obesity

Obesity Clinical Trial

Official title:

Pilot Project on Interdisciplinary Therapy of Obesity and Its Consequences on Body Weight, Quality of Life and Gastrointestinal Parameters

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01344525
• Other study ID #: OGIT-FKZ01GI0843
• Status: Recruiting
• Phase: N/A
• Start date: May 2009
• Est. completion date: May 2029

Study information

• Verified date: October 2018
• Source: University of Hohenheim
• Contact: Antje Damms-Machado, Dipl. troph.
• Phone: +49 711 451017707
• Email: antje.machado[@]uni-hohenheim.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: May 2029
• Est. primary completion date: May 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Procedure:
• Laparoscopic gastric sleeve
Laparoscopic gastric sleeve
• Gastric Banding
Gastric Banding
• Multidisciplinary lifstyle intervention
Multidisciplinary lifstyle intervention (OPTIFAST®52-program)
• Roux-en-Y Bypass
Roux-en-Y Bypass

Locations

Country	Name	City	State
Germany	University of Heidelberg	Heidelberg
Germany	University of Hohenheim	Stuttgart
Germany	University of Tübingen	Tübingen

Sponsors (2)

Lead Sponsor	Collaborator
University of Hohenheim	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight loss		Every 6 months for a period of 3 years
Secondary	Quality of life	SF-36, IWQOL-lite	Every 6 months for a period of 3 years
Secondary	Physical examination	Weight, height, waist circumference, blood pressure, bioelectric impedance analysis, pulse etc.	Every 6 months for a period of 3 years
Secondary	Laboratory analysis	Fasting glucose; Glutamat-Pyruvat- Transaminase (GPT); Lipid parameters (cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides)	Every 6 months for a period of 3 years
Secondary	Vitamins/micronutrients	Vitamin B1, B6, B12, ß-carotene, niacin, folic acid, selen and oxidative metabolites	Every 3-6 months for a period of maximal 3 years
Secondary	Metabolomics, and Microflora analysis		Every 3-6 months for a period of maximal 3 years
Secondary	Liver fat	Liver sonography	Every 6 months for a period of 3 years
Secondary	gut permeability	assessed by the uptake of inert molecules	Every 6 months for a period of 3 years
Secondary	peripheral blood lipopolysaccharide concentrations		Every 6 months for a period of 3 years