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van CCT (UK)

van CCT (UK)

The effects of heme arginate treatment on insulin resistance and vascular dysfunction related to obesity.

- candidate number8330
- NTR NumberNTR2472
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-aug-2010
- Secondary IDs2010/192 CMO Arnhem - Nijmegen, the Netherlands
- Public TitleThe effects of heme arginate treatment on insulin resistance and vascular dysfunction related to obesity.
- Scientific TitleIn vivo induction of heme oxygenase-1 (HO-1) in the metabolic syndrome.
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedMetabolic syndrome, Insulin resistance, Endothelial dysfunction
- Inclusion criteria1. 18 - 70 years of age;
2. Both men and women;
3. Metabolic syndrome as defined by the presence of at least 3 out of 5 characteristics:
A. Elevated waist circumference;
B. Elevated triglycerides;
C. Reduced HDL cholesterol;
D. Elevated blood pressure;
E. Elevated fasting glucose.
- Exclusion criteria1. History of smoking within the past year;
2. Known diabetes;
3. History or signs of cardiovascular disease;
4. Use of antihypertensive, cardiac or other vasoactive medication.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 26-aug-2010
- planned closingdate1-apr-2011
- Target number of participants16
- InterventionsTwo treatment periods in a randomized order:
1. During one treatment period subjects will be treated intravenously with heme arginate (Normosang) 3 mg/kg on day 1 and 3;
2. During the other treatment period subjects will be treated intravenously with L-arginine 3,2 mg/kg on day 1 and 3.

Wash out period of 2 months in between.
- Primary outcomeInsulin sensitivity.
- Secondary outcome1. Endothelial function;
2. Anti-oxidant capacity of plasma.
- Timepoints1. Assessment of whole body glucose disposal (M-value) by euglycemic hyperinsulinemic clamp on day 5 of both treatment periods;
2. Assessment of forearm the vasodilator response to acetylcholine (forearm blood flow) by forearm plethysmography on day 3 of both treatment periods;
3. Assessment of anti-oxidant capacity of plasma by ferric reducing ability of plasma (FRAP) assay on day 5 of both treatment periods.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Dutch Diabetes Research Foundation
- PublicationsN/A
- Brief summaryBoth the metabolic syndrome (MetS) and type 2 diabetes mellitus (T2DM) are associated with oxidative stress and a stage of low grade inflammatory activation of adipose tissue and the vascular system. As pro-inflammatory cytokines reinforce insulin resistance, a vicious cycle of cumulating exposure to risk factors and inflammation of the vascular system and adipose tissue occurs. The cytoprotective enzyme heme oxygenase (HO-1), is well known for its powerful antioxidant and anti-inflammatory capacity. In vitro and animal studies convincingly show the beneficial effect of HO activity with regard to T2DM related insulin resistance and vascular dysfunction. We thus hypothesize that short term HO-1 induction by heme arginate infusion ameliorates insulin resistance and endothelial dysfunction in subjects with MetS.
Subjects with MetS will receive a three day treatment with heme arginate (intravenously administered on day 1 and 3 of one treatment period) in a randomized and cross-over design with a washout period of two months. The control treatment will consist of a three day treatment with L-arginine (intravenously administered on day 1 and 3 of the other treatment period). During both treatment periods, insulin sensitivity and endothelial function will be assessed by an euglycemic hyperinsulinemic clamp and by venous occlusion strain gauge plethysmography respectively. In addition, we will determine plasma markers of inflammation and anti-oxidant capacity of plasma and perform adipose tissue biopsies.
- Main changes (audit trail)
- RECORD11-aug-2010 - 5-sep-2010

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