Subjects suffer from the metabolic syndrome. Effects of study medication on insulin resistance and vascular function will be studied respectively. MedDRA version: 12.1 Level: LLT Classification code 10022489 Term: Insulin resistance MedDRA version: 12.1 Level: LLT Classification code 10052066 Term: Metabolic syndrome MedDRA version: 12.1 Level: LLT Classification code 10048554 Term: Endothelial dysfunction
Conditions
Sponsors
RUNMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At least 18 and not older than 70 years of age on the day of the first dosing. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations. Metabolic syndrome defined by at least three out of five criteria: Elevated waist circumference (women = 88, men = 102 cm). Elevated triglycerides or drug treatment (= 1.7 mmol/L). Reduced HDL-cholesterol or drug treatment (women =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Documented history of sensitivity/idiosyncrasy to medicinal products or excipients. History of smoking within the past year. History of or current abuse of drugs, alcohol or solvents. Known diabetes mellitus Fasting plasma glucose > 7.0 mmol/L or HbA1c > 6.2% Pregnancy or breast feeding (contraception for at least 3 months before inclusion is required for fertile women) Current use of antihypertensive, cardiac or other vasoactive medication Current use of acetylsalicylic acid Use of antioxidant vitamin supplements Inability to suspend the use of statins during trial participation Clinical evidence of cardiac or pulmonary disease Laboratory evidence of renal or hepatic abnormalities, defined as results exceeding twice the upper limit of normal range. Inability to understand the nature and extent of the trial and the procedures required. Participation in a drug trial within 60 days prior to the first dose. Febrile illness within 3 days before the first dose. Unconjugated hyperbilirubinemia (total bilirubin level > 10 µmol/L and a normal direct bilirubin level) suggesting the Gilbert Syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our main objective is to determine the effect of HO-1 induction by heme arginate infusion on insulin resistance related to MetS. ;Secondary Objective: Secondary objectives are to determine the effect on endothelial dysfunction, adipose tissue, markers for oxidative stress and vascular inflammation and indicators of HO activity.;Primary end point(s): Insulin sensitivity derived from the glucose infusion rate measured by euglycemic hyperinsulinemic clamps following treatment with Normosang and arginine. | — |
Countries
Netherlands
Outcome results
None listed