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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00009008 |
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Date of registration:
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11/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of bariatric surgery dependent weight loss on gut barrier function and the inflammatory status
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Scientific title:
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Effect of bariatric surgery dependent weight loss on gut barrier function and the inflammatory status |
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Date of first enrolment:
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13/03/2015 |
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Target sample size:
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60 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00009008 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: basic science
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Thomas
Skurk |
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Address:
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Gregor-Mendel-Straße 2
85354
Freising
Germany |
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Telephone:
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+49-(0)8161-71-2007 |
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Email:
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skurk@tum.de |
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Affiliation:
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Lehrstuhl für Ernährungsmedizin, Technische Universität München |
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Name:
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Teresa
Kellerer |
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Address:
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Gregor-Mendel-Straße 2
85354
Freising
Germany |
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Telephone:
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+49-(0)8161-71-2011 |
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Email:
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teresa.kellerer@tum.de |
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Affiliation:
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Lehrstuhl für Ernährungsmedizin, Technische Universität München |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Obesity
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E66
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Intervention(s)
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Group 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.
Group 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.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Else Kröner-Fresenius Zentrum für Ernährungsmedizn, Lehrstuhl für Ernährungsmedizin, Technische Universität München
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Deutsche Forschungsgemeinschaft, Graduiertenkolleg 1482
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Ethics review
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Status: Approved
Approval date: 25/02/2015
Contact:
ethikkommission@mri.tum.de
Ethikkommission der Fakultät für Medizin der Technischen Universität München
+49-89-41404371
ethikkommission@mri.tum.de
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