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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Weight Loss
• Intervention / Treatment: Procedure: Multidisciplinary lifstyle intervention; Procedure: Laparoscopic gastric sleeve; Procedure: Gastric Banding; Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antje Damms-Machado, Dipl. troph.; Phone Number: +49 711 451017707; Email: antje.machado@uni-hohenheim.de
• Study Contact Backup: Name: Katrin Stingel, Dipl. troph.; Phone Number: +49 711 451017705; Email: k_stingel@uni-hohenheim.de

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • University of Heidelberg
  • Stuttgart, Germany, 70599
    • Recruiting
    • University of Hohenheim
  • Tübingen, Germany, 72076
    • Recruiting
    • University of Tubingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body weight loss	Every 6 months for a period of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	SF-36, IWQOL-lite	Every 6 months for a period of 3 years
Physical examination	Weight, height, waist circumference, blood pressure, bioelectric impedance analysis, pulse etc.	Every 6 months for a period of 3 years
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
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
Metabolomics, and Microflora analysis		Every 3-6 months for a period of maximal 3 years
Liver fat	Liver sonography	Every 6 months for a period of 3 years
gut permeability	assessed by the uptake of inert molecules	Every 6 months for a period of 3 years
peripheral blood lipopolysaccharide concentrations		Every 6 months for a period of 3 years

Collaborators and Investigators

• Sponsor: University of Hohenheim
• Collaborators: German Federal Ministry of Education and Research
• Investigators: Principal Investigator: Stephan C. Bischoff, Prof. Dr., University of Hohenheim, Institute of Nutritional Medicine

Publications and helpful links

General Publications

• Damms-Machado A, Louis S, Schnitzer A, Volynets V, Rings A, Basrai M, Bischoff SC. Gut permeability is related to body weight, fatty liver disease, and insulin resistance in obese individuals undergoing weight reduction. Am J Clin Nutr. 2017 Jan;105(1):127-135. doi: 10.3945/ajcn.116.131110. Epub 2016 Nov 9.
• Damms-Machado A, Mitra S, Schollenberger AE, Kramer KM, Meile T, Konigsrainer A, Huson DH, Bischoff SC. Effects of surgical and dietary weight loss therapy for obesity on gut microbiota composition and nutrient absorption. Biomed Res Int. 2015;2015:806248. doi: 10.1155/2015/806248. Epub 2015 Feb 1.
• Damms-Machado A, Weser G, Bischoff SC. Micronutrient deficiency in obese subjects undergoing low calorie diet. Nutr J. 2012 Jun 1;11:34. doi: 10.1186/1475-2891-11-34.
• Damms-Machado A, Friedrich A, Kramer KM, Stingel K, Meile T, Kuper MA, Konigsrainer A, Bischoff SC. Pre- and postoperative nutritional deficiencies in obese patients undergoing laparoscopic sleeve gastrectomy. Obes Surg. 2012 Jun;22(6):881-9. doi: 10.1007/s11695-012-0609-0.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Anticipated): May 1, 2029
• Study Completion (Anticipated): May 1, 2029

Study Registration Dates

• First Submitted: April 27, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (Estimate): April 29, 2011

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: outcome; micronutrients; metabolic syndrome; microbiota; metabolomics; sustainability; gastrointestinal tract; obesity therapy
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss
• Other Study ID Numbers: OGIT-FKZ01GI0843