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NCT Number: NCT01344525

Pilot Project on Interdisciplinary Therapy of Obesity

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Heidelberg, Heidelberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic gastric sleeve

Procedure

Laparoscopic gastric sleeve

Gastric Banding

Procedure

Gastric Banding

Multidisciplinary lifstyle intervention

Procedure

Multidisciplinary lifstyle intervention (OPTIFAST®52-program)

Roux-en-Y Bypass

Procedure

Roux-en-Y Bypass

Primary outcomes

  1. Body weight loss

    Time frame: Every 6 months for a period of 3 years

Secondary outcomes

  1. Quality of life

    Time frame: Every 6 months for a period of 3 years

    SF-36, IWQOL-lite

  2. Physical examination

    Time frame: Every 6 months for a period of 3 years

    Weight, height, waist circumference, blood pressure, bioelectric impedance analysis, pulse etc.

  3. Laboratory analysis

    Time frame: Every 6 months for a period of 3 years

    Fasting glucose; Glutamat-Pyruvat- Transaminase (GPT); Lipid parameters (cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides)

  4. Vitamins/micronutrients

    Time frame: Every 3-6 months for a period of maximal 3 years

    Vitamin B1, B6, B12, ß-carotene, niacin, folic acid, selen and oxidative metabolites

  5. Metabolomics, and Microflora analysis

    Time frame: Every 3-6 months for a period of maximal 3 years

  6. Liver fat

    Time frame: Every 6 months for a period of 3 years

    Liver sonography

  7. gut permeability

    Time frame: Every 6 months for a period of 3 years

    assessed by the uptake of inert molecules

  8. peripheral blood lipopolysaccharide concentrations

    Time frame: Every 6 months for a period of 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Antje Damms-Machado, Dipl. troph.

CONTACT

[email protected]

+49 711 451017707

Katrin Stingel, Dipl. troph.

CONTACT

[email protected]

+49 711 451017705

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2029
Study completion
2029
First posted
Apr 29, 2011
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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