AzTrials
AzTrials

ObesityNCT01344525

Pilot Project on Interdisciplinary Therapy of Obesity

A study testing Laparoscopic gastric sleeve, Gastric Banding and Multidisciplinary lifstyle intervention in people with Obesity and Weight Loss, run by University of Hohenheim at 3 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity, Weight Loss
What is being tested?
Laparoscopic gastric sleeve, Gastric Banding and Multidisciplinary lifstyle intervention
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
3 sitesGermany
Study dates
May 2009to May 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Body weight loss after intervention < 10%
  • Follow-up period < 1 year or number of consultations within 3 years < 3

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Antje Damms-Machado, Dipl. troph. contact

+49 711 451017707

antje.machado@uni-hohenheim.de

Katrin Stingel, Dipl. troph. contact

+49 711 451017705

k_stingel@uni-hohenheim.de

Germany3 sites, 3 recruiting

  • University of Heidelberg

    Heidelberg, 69120

    Recruiting

  • University of Hohenheim

    Stuttgart, 70599

    Recruiting

  • University of Tübingen

    Tübingen, 72076

    Recruiting

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Conditions
Obesity, Weight Loss
Being tested
Laparoscopic gastric sleeve, Gastric Banding, Multidisciplinary lifstyle intervention, Roux-en-Y Bypass
Keywords
obesity therapy, metabolic syndrome, gastrointestinal tract, microbiota, metabolomics, micronutrients, outcome, sustainability
Medical subject headings
Obesity, Weight Loss, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic gastric sleeveProcedure or surgery

    Laparoscopic gastric sleeve

  • Gastric BandingProcedure or surgery

    Gastric Banding

  • Multidisciplinary lifstyle interventionProcedure or surgery

    Multidisciplinary lifstyle intervention (OPTIFAST®52-program)

  • Roux-en-Y BypassProcedure or surgery

    Roux-en-Y Bypass

Study groups in NCT01344525
Study groupRoleWhat they receive
Control groupNo interventionNutritional counselings every 6 months, no further intervention
"low-calorie-diet (LCD)"-based lifestyle interventionExperimental12 months multidisciplinary weight loss program including three months low-calorie formula diet (800 kcal) (OPTIFAST®52 program)
Receives: Procedure: Multidisciplinary lifstyle intervention
Laparoscopic gastric sleeve interventionExperimentalNot described
Receives: Procedure: Laparoscopic gastric sleeve
Conventional bariatric surgeryExperimentalGastric Banding and Gastric Bypass
Receives: Procedure: Gastric Banding; Procedure: Roux-en-Y Bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body weight loss

    Measured: Every 6 months for a period of 3 years

Secondary outcomes (8)

  1. Quality of life

    SF-36, IWQOL-lite

    Measured: Every 6 months for a period of 3 years

  2. Physical examination

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

    Measured: Every 6 months for a period of 3 years

  3. Laboratory analysis

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

    Measured: Every 6 months for a period of 3 years

  4. Vitamins/micronutrients

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

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

  5. Metabolomics, and Microflora analysis

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

  6. Liver fat

    Liver sonography

    Measured: Every 6 months for a period of 3 years

  7. gut permeability

    assessed by the uptake of inert molecules

    Measured: Every 6 months for a period of 3 years

  8. peripheral blood lipopolysaccharide concentrations

    Measured: Every 6 months for a period of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2011 (estimated)
  2. Study startMay 2009
  3. Primary completionMay 2029 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01344525
Sponsor's protocol ID
OGIT-FKZ01GI0843
Status last verified
Oct 2018
First submitted
27 Apr 2011
Last updated
26 Oct 2018
Results posted
No

Publications

  • Seethaler B, Basrai M, Delzenne NM, Walter J, Nguyen NK, Bischoff SC. Baseline gut microbiome and metabolome profiles predict weight loss after a structured lifestyle intervention. Microbiome. 2026 Aug 28;14(1):207. doi: 10.1186/s40168-026-02501-x.

    PubMed 42668355

  • 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.

    PubMed 28049662

  • 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.

    PubMed 25710027

  • 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.

    PubMed 22657586

  • 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.

    PubMed 22403000

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic gastric sleeve, Gastric Banding and Multidisciplinary lifstyle intervention in people with Obesity and Weight Loss, run by University of Hohenheim at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Antje Damms-Machado, Dipl. troph. (+49 711 451017707, antje.machado@uni-hohenheim.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body weight loss (time frame: Every 6 months for a period of 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01344525, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.

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