|- candidate number||8083|
|- NTR Number||NTR2335|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-mei-2010|
|- Secondary IDs||29210 CCMO|
|- Public Title||IMAGE trial: Intestinal Microbiota & Adipose Gene Expression.|
|- Scientific Title||IMAGE trial: Intestinal Microbiota & Adipose Gene Expression.|
|- ACRONYM||IMAGE trial|
|- hypothesis||We 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) studied||Obesity, Gut microbiota, Fat adipose tissue|
|- Inclusion criteria||1. Healthy men and women, scheduled for elective laparoscopic cholecystectomy;|
2. Age 18-85 yrs;
3. BMI 18-45 kg/m2.
|- Exclusion criteria||1. Generalized inflammation;|
2. Antibiotic use last three months;
3. Malignant disease;
4. Metformin use.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jun-2010|
|- planned closingdate||1-jun-2013|
|- Target number of participants||200|
|- Interventions||During 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 outcome||Expression of genes in adipose tissue will be compared to gut microbiota composition.|
|- Secondary outcome||We will try to relate regulation of genes to plasma markers of inflammation.|
|- Timepoints||Cross-sectional design, only 1 timepoint.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. A. Vrieze|
|- CONTACT for SCIENTIFIC QUERIES||Drs. A. Vrieze|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||Objective: 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)|
|- RECORD||25-mei-2010 - 5-jun-2010|