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.

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•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)

•History of smoking within the past year.
•History of or current abuse of drugs, alcohol or solvents.
•Known diabetes mellitus
•Repeated systolic blood pressure >= 180 mm Hg in all subjects, >= 160 mm Hg in women >= 65 yrs old and >= 140 mm Hg in men >= 65 yrs old
•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 and/or statin
•Use of antioxidant vitamin supplements
•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.
•Unconjugated hyperbilirubinemia (total bilirubin level > 10 µmol/L and a normal direct bilirubin level) suggesting the Gilbert Syndrome.

发起方

niversitair Medisch Centrum Sint Radboud