Effect of bariatric surgery dependent weight loss on gut barrier function and the inflammatory status
Organizational Data
- DRKS-ID:
- DRKS00009008
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2016-08-11
- Last update in DRKS:
- 2021-04-12
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
http://www.kem.wzw.tum.de/index.php?id=91
Brief summary in lay language
In this study extremely obese patients take part, that undergo a surgery procedure to reduce stomach size for effective weight loss. Besides, normal- to moderately overweight control patients participate. The aim of the study is to address the question if the surgery procedure and the associated weight loss alter gut barrier function. The background to this is the hypothesis, that overweight increases the permeability of the gut, so that certain substances, like bacterial products, can enter the bloodstream more easily causing an inflammatory response of the body. Hence inflammatory factors in blood and fat tissue are measured in the study. Moreover, the composition of the bacterial community in the gut is analysed. These three factors (gut barrier function, inflammatory status and bacterial community in the gut) influence each other.
Brief summary in scientific language
The aim of the study is to investigate the effect of obesity and excessive weight loss after bariatric surgery, namely sleeve gastrectomy, on the intestinal permeability. Furthermore, the aim is to examine the link between intestinal permeability and local, respectively systemic inflammation. Therefore, the intestinal permeability, the microbial composition of the colon and the inflammatory status in fat tissue are investigated in severely obese patients before and after bariatric surgery in comparison to normal weight to morderately overweight subjects.
Health condition or problem studied
- ICD10:
- E66 - Obesity
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 20-30 obese patients (BMI ≥ 40 kg/m2) undergoing laparoscopic sleeve gastrectomy are included in the study. Before and six months after surgery the intestinal permeability is investigated by means of a sugar resorption test. Furthermore, the microbial composition of the colon, the eating behaviour (7 day dietary protocol), blood parameters (glucose, insulin, inflammatory parameters, electrolytes, blood lipids) and anthrompometric data (weight, waist and hip circumference) are analysed. During operation, visceral and subcutaneous fat tissue probes are taken for determination of the inflammatory status in the fat tissue.
- Arm 2:
- 20-30 normal weight to moderately overweight control subjects (BMI < 30 kg/m2) are included in the study. In the control group the same paramters are analyses as in the bariatric surgery group. Control patients with or without an abdominal surgery procedure (for access of fat tissue) are recruited.
Endpoints
- Primary outcome:
- intestinal permeability: sugar resorption test; change in microbial composition of the colon: faecal sample, metagenomic sequencing of faecal microbiota; inflammatory parameters in blood: blood samples, CRP; marker of intestinal permeability in blood: blood samples, zonulin and LPS-binding protein; all parameters are measured before as well as six months after sugery in the obese patients and once in the control patients
- Secondary outcome:
- anthropometry: body weight as well as waist-to-hip ratio; eating habits: 7 day dietary protocol; fasting insulin, fasting glucose, HbA1c: blood samples, laboratory analysis all parameters are measured before as well as six months after sugery in the obese patients and once in the control patients
Study Design
- Purpose:
- Basic research/physiological study
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Krankenhaus Landshut Achdorf Landshut
- Medical center Krankenhaus Landshut Achdorf Landshut
- Medical center Chirurgische Klinik München-Bogenhausen München
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2015-03-13
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2017-07-14
- Target Sample Size:
- 60
- Final Sample Size:
- 48
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 65 Years
- Additional Inclusion Criteria:
- written informed consent, BMI ≥ 40 kg/m² for the bariatric surgery group, BMI < 30 kg/m² for the control group
Exclusion Criteria
absent written informed consent, poor complicance, serious illness, e.g. cancer, COPD, serious hart disease (e.g. pacemaker), serious mental illness, liver illness (AST, ALT > 3fold of normal value), renal disease (creatinine > 1.2 mg/dl), serious gastrointestinal, neurological, rheumatic illness, celiac disease, acute infections, hypokalemia, insulin-dependent diabetes mellitus, regular intake of antibiotics, immunesuppressants, laxatives, anti-diarrhea medication, malabsorption syndrome, autonomic neuropathy, lactulose intolerance, sucralose intolerance, sucrose intolerance
Addresses
Primary Sponsor
- Address:
- Else Kröner-Fresenius Zentrum für Ernährungsmedizn, Lehrstuhl für Ernährungsmedizin, Technische Universität MünchenProf. Dr. med. Hans HaunerGregor-Mendel Straße 285354 FreisingGermany
- Telephone:
- +49-(0)8161-71-2001
- Fax:
- +49-(0)8161-71-2097
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.em-tum.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Lehrstuhl für Ernährungsmedizin, Technische Universität MünchenPD Dr. med. Thomas SkurkGregor-Mendel-Straße 285354 FreisingGermany
- Telephone:
- +49-(0)8161-71-2007
- Fax:
- +49-(0)8161-71-2097
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.em-tum.de
Contact for Public Queries
- Address:
- Lehrstuhl für Ernährungsmedizin, Technische Universität MünchenM.Sc. Teresa KellererGregor-Mendel-Straße 285354 FreisingGermany
- Telephone:
- +49-(0)8161-71-2011
- Fax:
- +49-(0)8161-71-2097
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.em-tum.de
Principal Investigator
- Address:
- Lehrstuhl für Ernährungsmedizin, Technische Universität MünchenPD Dr. med. Thomas SkurkGregor-Mendel-Straße 285354 FreisingGermany
- Telephone:
- +49-(0)8161-71-2007
- Fax:
- +49-(0)8161-71-2097
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.em-tum.de
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Deutsche Forschungsgemeinschaft, Graduiertenkolleg 1482Kennedyallee 4053175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dfg.de
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Else Kröner-Fresenius Zentrum für Ernährungsmedizn, Lehrstuhl für Ernährungsmedizin, Technische Universität MünchenGregor-Mendel Straße 285354 FreisingGermany
- Telephone:
- +49-(0)8161-71-2001
- Fax:
- +49-(0)8161-71-2097
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.em-tum.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Fakultät für Medizin der Technischen Universität MünchenIsmaninger Str. 2281675 MünchenGermany
- Telephone:
- +49-89-41404371
- Fax:
- +49-89-41404199
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2014-09-23
- Ethics committee number:
- 387/14
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2015-02-25
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Kellerer, T., Brandl, B., Büttner, J., Lagkouvardos, I., Hauner, H., and Skurk, T. (2019). Impact of Laparoscopic Sleeve Gastrectomy on Gut Permeability in Morbidly Obese Subjects. Obesity surgery 29, 2132-2143.. https://doi.org/10.1007/s11695-019-03815-6
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry