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The effect of diet-induced changes in intestinal mucus and microbiota composition on the development of type 2 diabetes and non-alcoholic fatty liver disease


- candidate number23940
- NTR NumberNTR5660
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-feb-2016
- Secondary IDsNL52416.015.15 
- Public TitleThe effect of diet-induced changes in intestinal mucus and microbiota composition on the development of type 2 diabetes and non-alcoholic fatty liver disease
- Scientific TitleDiet-Induced Alteration of Microbiota and development of Obesity, Non-alcoholic fatty liver disease and Diabetes
- ACRONYMDIAMOND-study
- hypothesisModulation of Paneth cell and/or goblet cell function by increased lipid intake underlies the microbiota alterations that promote obesity, type 2 diabetes and non-alcoholic fatty liver disease.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus, Obesity
- Inclusion criteriaGroup 1
BMI > 40 kg/m2 of >35 kg/m2 with comorbidities
Age between 18 and 60 years

Group 2 and 3
BMI 20-25 kg/m2
Age between 18 and 60 years
- Exclusion criteriaGroup 1
Type 1 diabetes
Alcohol or drug abuse according to DSM-V
Inflammatory disease, such as auto-immune disease
Degenerative diseases
Doctor-prescribed use of corticosteroids or prednisolon
Use of antibiotics in the three months prior to surgery

Group 2 and 3
Type 1 or type 2 diabetes
Cachexia, defined as weight loss (<5% in a month or >10% in 6 months) or a BMI <20kg/m2
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 10-feb-2016
- planned closingdate1-aug-2017
- Target number of participants228
- InterventionsGroup 1: Roux-en-Y gastric bypass
Group 2: laparoscopic cholecystectomy
Group 3: upper GI endoscopy
- Primary outcomefecal and intestinal microbiota composition
mucus composition, Paneth cell phenotype
- Secondary outcomebody weight, BMI, abdominal circumference, composition diet, ...
- TimepointsPreoperative (baseline), 12 months postoperative
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD candidate Martine Uittenbogaart
- CONTACT for SCIENTIFIC QUERIESMD, PhD candidate Martine Uittenbogaart
- Sponsor/Initiator Máxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Maxima Medical Center, Maastricht University Medical Center (MUMC+)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD9-feb-2016 - 20-mrt-2016


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