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IMAGE trial: Intestinal Microbiota & Adipose Gene Expression.


- candidate number8083
- NTR NumberNTR2335
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-mei-2010
- Secondary IDs29210 CCMO
- Public TitleIMAGE trial: Intestinal Microbiota & Adipose Gene Expression.
- Scientific TitleIMAGE trial: Intestinal Microbiota & Adipose Gene Expression.
- ACRONYMIMAGE trial
- hypothesisWe hypothesize that genetically programmed developmental differences in adipocytes are under direct regulation of fecal flora composition which thus plays an important role in obesity, body fat distribution ans systhemic inflammation.
- Healt Condition(s) or Problem(s) studiedObesity, Gut microbiota, Fat adipose tissue
- Inclusion criteria1. Healthy men and women, scheduled for elective laparoscopic cholecystectomy;
2. Age 18-85 yrs;
3. BMI 18-45 kg/m2.
- Exclusion criteria1. Generalized inflammation;
2. Antibiotic use last three months;
3. Malignant disease;
4. Metformin use.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2010
- planned closingdate1-jun-2013
- Target number of participants200
- InterventionsDuring the planned surgery visceral and subcutaneous biopsies will be obtained. In all patients venous blood samples will be taken and the patients will collect a feces sample.
- Primary outcomeExpression of genes in adipose tissue will be compared to gut microbiota composition.
- Secondary outcomeWe will try to relate regulation of genes to plasma markers of inflammation.
- TimepointsCross-sectional design, only 1 timepoint.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. A. Vrieze
- CONTACT for SCIENTIFIC QUERIESDrs. A. Vrieze
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryObjective: To investigate correlations between gene expression in adipocytes and gut microbiota composition in relation to plasma markers of inflammation.

Study design: Cross-sectional design.

Study Population: Healthy men and women scheduled for elective laparoscopic cholecystectomy.

Outcome measures: Expression of human genes will be first tested on Affimetrix microarrays and genes of interest will thereafter be assessed by quantitative real-time RT-PCR. These genes in adipose tissue will be compared to gut microbiota composition. Finally we will try to relate regulation of genes to plasma markers of inflammation. Sample Size: It is estimated that a total of 200 patients (100 males and 100 females) are needed.
- Main changes (audit trail)
- RECORD25-mei-2010 - 5-jun-2010


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