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Pilot Project on Interdisciplinary Therapy of Obesity

NCT01344525 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2018-10-26

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • University of Hohenheim

    lead OTHER

Principal Investigators

  • Stephan C. Bischoff, Prof. Dr. · University of Hohenheim, Institute of Nutritional Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2029-05-31
Completion
2029-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01344525 on ClinicalTrials.gov