In vivo induction of heme oxygenase-1 (HO-1) in the metabolic syndrome (MetS).Influence of heme arginate (Normosang) infusion on heme oxygenase-1 activity, endothelial dysfunction, insulin resistance and adipose tissue inflammation related to the metabolic syndrome - In vivo induction of HO in MetS.

RUNMC0 个研究点目标入组 16 人开始时间: 2010年6月24日最近更新: 2021年12月21日

适应症

试验速览

暂无简介。

•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 < 1.3 mmol/L, men < 1.0 mmol/L).
•Elevated blood pressure (systolic = 130 mm Hg and/or diastolic = 85 mm Hg)
•Elevated fasting glucose (= 6.1 mmol/L)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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.

发起方

RUNMC