familiarity for matabolic syndrome
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Magnesium pidolate
Concentration unit: mmol millimole(s)
Concentration type: equal
Concentration number: 8.1-
Pharmaceutical form of the placebo
Sponsors
AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy subjects, non suffering Hypertension, non diabetic, non obese, at the age between 18 and 50 years, with at least a relative suffering from metabolic syndrome (NCEP/ATPIII criteria). 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
Exclusion criteria
Exclusion criteria: Age below 18 and over 50, hypertension (BP≥140/90 mmHg or therapy with antihypertensive drugs), diabetes mellitus (Glycemia on empty stomach ≥126 mg/dl or therapy with antidiabetic drugs), obesity (BMI≥30 Kg/m2). Intake of hypocholesteromizant drugs, NSAIDs or other type (if continuative use). Use of magnesium supplementations or vitamin complexes. Hypermagnesemia before randomization. Previous cardiac and/or cerebrovascular events. Chronic kidney failure. Chronic inflammatory liver or renal diseases, malignant cancer, gastrointestinal dysfunctions with hypomotility. Unability to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study will evaluate the possible effects on blood pressure of magnesium supplementation by oral route for 8 weeks versus placebo in a group of 15 subjects with familiarity for arterial hypertension joined diabetes type II and/or metabolic syndrome.;Primary end point(s): The primary endpoint will be the efficacy of this treatment on blood pressure: measured as office blood pressure in supine position (3 times at the distance of 5 minutes each others) with a semiautomatic oscillometric device.;Secondary Objective: To explore the possible mechanisms through magnesium acts on blood pressure will be also explored : 1. the endothelial function explored with non invasive echographia (dependent vasodilatation flow, FMD) 2. HOMA index given from the product of glycemia and plasmatic insulinemia in abstinence from food (on empty stomach) 3. the arterial rigidity explores with non invasive tonometric and photoplethysmographic methods. 4. Evaluation of thye homeostasis of intracellular magnesium. | — |
Countries
Italy
Outcome results
None listed