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RBP4 and glucose metabolism.


- candidate number14312
- NTR NumberNTR3835
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-feb-2013
- Secondary IDs12/314 METC AMC
- Public TitleRBP4 and glucose metabolism.
- Scientific TitleThe role of RBP4 in human glucose metabolism.
- ACRONYMRBP
- hypothesisLiver and adipose tissue levels as well as serum levels of RBP4 are higher in obese subjects compared to lean subjects. In obese subjects tissue and serum levels of RPB4 are correlated with insulin sensitivity and hepatic triglyceride content.
- Healt Condition(s) or Problem(s) studiedObesity, Diabetes Mellitus type 2 (DM type II), Insulin resistance
- Inclusion criteria1. Female;
2. BMI > 35 kg/m2;
3. Age between 26 and 50 years;
4. Established T2DM.
- Exclusion criteria1. Primary lipid disorder or secondary lipid disorder treated with fibrates;
2. T2DM treated with thiazolidinediones, DPP4-inhibitors or GLP1-analogues;
3. Any medical condition except for glucose intolerance, hypertension and secondary dyslipidemia;
4. Bleeding disorder;
5. Untreated primary hypothyroidism;
6. Contra-indications for MR scanning.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 4-feb-2013
- planned closingdate31-dec-2013
- Target number of participants10
- InterventionsN/A
- Primary outcomeCirculating and tissue levels of RBP4, in relation to:
1. Endogenous glucose production;
2. Hepatic, peripheral and adipose tissue insulin sensitivity;
3. Hepatic triglyceride content.
- Secondary outcomeCorrelation levels of RBP4 with hepatic enzymes involved in gluconeogenesis.
- Timepoints1. Screening;
2. Two weeks presurgery;
3. Surgery.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Murat Kilicarslan
- CONTACT for SCIENTIFIC QUERIES M.J.M. Serlie
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryRetinol binding protein (RBP4) is a small 21 kDa protein that belongs to the family of lipocalins. RBP4 is primarily synthesized in hepatocytes, but other sites of synthesis are known including adipocytes. Recently RBP4 has been proposed as an adipokine that is involved in obesity-induced insulin resistance. We aim to assess whether serum and tissue RBP4 levels are elevated in these metabolically altered states and whether these levels are correlated with glucose fluxes. This gives more insight in the pathophysiological role of RBP4 in glucose intolerance and diabetes in obesity and will shed light on whether it would be useful to develop agents that decrease RBP4 expression.
- Main changes (audit trail)
- RECORD3-feb-2013 - 13-feb-2013


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