E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
familiarity for matabolic syndrome |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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). |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |