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van CCT (UK)

van CCT (UK)

Systeembiologische aanpak van de oorzaken en onderlinge verbanden van kenmerken van het metabool syndroom

- candidate number18262
- NTR NumberNTR4666
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-jul-2014
- Secondary IDsNL43917.018.13 
- Public TitleSysteembiologische aanpak van de oorzaken en onderlinge verbanden van kenmerken van het metabool syndroom
- Scientific TitleA systems biology approach to RESOLVE the molecular pathology of the hallmarks of patients with metabolic syndrome and its co-morbidities; Hypertriglyridemia, low HDL-cholesterol and loss of glycemic control
- hypothesisMetabolically healthy obese subjects are characterized by increased adipose tissue expression of genes involved in triglyceride storage, lower inflammatory changes and lower ectopic lipid accumulation compared to metabolically unhealthy subjects. This metabolically healthy phenotype is associated with higher insulin sensitivity and lower VLDL secretion.
- Healt Condition(s) or Problem(s) studiedMetabolic syndrome, Insulin resistance, Dyslipemia, Bariatric surgery
- Inclusion criteria- scheduled for bariatric surgery (Roux-en-Y gastric bypass)
- 18-65 years of age
- ability to provide informed consent
- stable weight 3 months prior to inclusion
- willingness to stop lipid lowering and antiacid medication 4 weeks prior to study measurements
- Exclusion criteria- use of exogenous insulin, GLP-1 agonists or DPP-4 inhibitors
- all medica! and psychiatric conditions except for obesity-related diseases
- primary lipid disorder
- childhood onset obesity
- coagulation disorders
- uncontrolled hypertension
- renal insufficiency
- excessive alcohol intake
- contraindication to MRI scanning
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-aug-2014
- planned closingdate1-aug-2016
- Target number of participants44
- Interventionsnone
- Primary outcome- tissue gene expression in relation to glucose/lipid/lipoprotein fluxes
- Secondary outcome- liver fat in relation to liver gene expression profiles and metabolic fluxes
- parasympathetic/sympathetic balance and energy expenditure
- gut microbiota composition in relation to metabolic fluxes
- fructose tolerance
- Timepoints- baseline (t = 0)
- study measurements (t = 1 to 3 weeks)
- follow-up (t = 1 to 12 months)
- Trial web site
- statusinclusion stopped: follow-up
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
European Union
- Publications
- Brief summaryMetabolic syndrome in obesity is associated with disturbances in lipid and glucose metabolism. Insulin resistance, glucose intolerance and dyslipidemia co-occur in most cases and are diagnostic criteria for the metabolic syndrome. The interactions between these perturbations in the metabolism of HDL-cholesterol (HDL-C), triglycerides (TG) and glucose are complex. There appears to be a broad variety between individuals regarding the metabolic handling of excess calories. Resulting in metabolic subtypes of obese persons, with obese subjects being either relatively insulin sensitive with normal plasma lipids (metabolically healthy) or insulin resistant with low HDL-C and high TG (metabolically unhealthy). It is proposed that differences in tissue expression of genes involved in glucose and lipid metabolism may play a role in the development of the metabolic syndrome. Unraveling the interaction between gene expression and glucose and lipid metabolism in these subgroups of obese adults is of interest, because pathophysiological insight will lead to novel treatment targets.
We propose to study the interaction between tissue expressions of genes involved in glucose and lipid metabolism in relation to metabolic fluxes in 44 metabolically healthy and unhealthy morbidly obese men and women scheduled for Roux-en-Y gastric bypass surgery.
Metabolic fluxes (i.e. carbohydrate/glucose, lipid and lipoprotein) will be studied on 3 study days prior to bariatric surgery. Subjects will keep a diet journal and collect feces samples. Hepatic steatosis will be assessed by MRS. Biopsies from liver, adipose tissue compartments will be taken during bariatric surgery. Muscle biopsies will be taken during hyperinsulinemia.
- Main changes (audit trail)
- RECORD2-jul-2014 - 19-mei-2017

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