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Interdisciplinary Therapy Impact on Obesity, Body Weight, Quality of Life and Gastrointestinal Parameters

Study Aim

This study aims to evaluate the impact of interdisciplinary therapy on body weight loss, quality of life, and gastrointestinal parameters in individuals struggling with obesity.

What is being tested

Laparoscopic gastric sleeve

+ Gastric Banding

+ Roux-en-Y Bypass

Procedure

Who is being recruted

Body Weight+12

+ Body Weight Changes

+ Hyperinsulinism

From 18 to 65 Years

+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: May 2009

See protocol details

Summary

Principal SponsorUniversity of Hohenheim

Study ContactAntje Damms-Machado, Dipl. troph.More contacts

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2009

Actual date on which the first participant was enrolled.

This study focuses on understanding the role of the gut in the development of obesity and related diseases like fatty liver in humans. It aims to help classify individuals based on risk or outcome after intervention. The study involves 480 obese individuals who will undergo either surgical or non-surgical treatment programs. The importance of this research lies in its potential to improve care for obese individuals by identifying gastrointestinal parameters that can predict the outcome and sustainability of different treatments. During the 3-year study, participants will visit the obesity center every 6 months for check-ups. These visits include measurements like Body Mass Index (BMI), excess body weight, and bioelectrical impedance analysis. Participants will also complete quality of life questionnaires and provide samples for laboratory analyses to check various health markers. The main goal is to measure body weight loss as a primary outcome. The study also aims to compare different intervention programs in terms of long-term outcomes and changes in quality of life.

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

NCT01344525

Principal SponsorUniversity of Hohenheim

Study ContactAntje Damms-Machado, Dipl. troph.More contacts

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

480 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightBody Weight ChangesHyperinsulinismInsulin ResistanceMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsWeight LossMetabolic SyndromeOvernutritionGlucose Metabolism DisordersOverweight

Criteria

3 inclusion criteria required to participate

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

2 exclusion criteria prevent from participating

Body weight loss after intervention < 10%

Follow-up period < 1 year or number of consultations within 3 years < 3

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Gastric Banding and Gastric Bypass

Group III

Experimental

12 months multidisciplinary weight loss program including three months low-calorie formula diet (800 kcal) (OPTIFAST®52 program)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Recruiting

University of Heidelberg

Heidelberg, GermanyOpen University of Heidelberg in Google Maps

Recruiting

University of Hohenheim

Stuttgart, Germany

Recruiting

University of Tübingen

Tübingen, Germany

Recruiting

3 Study Centers