Obesity associated arterial hypertension Metabolic syndrome associated arterial hypertension
Conditions
Interventions
Trade Name: Deltius
Pharmaceutical Form: Oral liquid
Sponsors
Núcleo de Estudos de Hipertensão da Beira Interior
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Obtention of free and informed consent to participate, dated and signed by the participant - Free willing and availability to participate in the all course of the trial as well as to accomplish with all the procedures of the trial protocol - Hability to take autonomously oral medication and capacity to adhere to the therapeutic scheme proposed by the trial - In women of child-bearing potential use of efficacious contraception - Age between 45-65 years - Treated essential hypertension (systolic blood pressure ¿ 159 mmHg and diastolic blood pressure ¿ 99 mmHg) - Obesity (body mass index ¿ 30 Kg/m2) or metabolic syndrome by the International Diabetes Federation 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Actual or previous medication with modulatores of the immune system (e.g. steroids, immunossupressive medication) - Actual treatment with antihistamines - Autoimmmune disease - Sarcoidosis - Active infectious or neoplasic disease - Other chronic infectious or inflammatory diseases (e.g. tuberculosis, diabetic foot, chronic viral hepatitis) - Glomerular filtration rate 10.5 mg/dL - Kidney stones or nephrocalcinosis - Active smoker - Active treatment with cholecalciferol before the beggining of the trial - Pregnacy, breastfeeding or non-utilization of efficacious contraceptive method - Intolerance to cholecalciferol - Simultaneous participation in another trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the percentage of TCD4+, TCD8+, Th17 and T regulatory cells in the serum of hypertensive patients with obesity and/or metabolic syndrome (O/MS) associated hypertension before and after 24 weeks of cholecalciferol supplementation. ;Secondary Objective: 1.Compare the metabolic profile (glutamine and glutamate concentrations) in the serum of hypertensive patients with O/MS associated hypertension before and after 24 weeks of cholecalciferol supplementation. 2.Compare the percentage of macrophages and T limphocytes in subcutaneous abdominal adipose tissue of hypertensive patients with O/MS associated hypertension before and after 24 weeks of cholecalciferol supplementation. 3.Compare insulin-resistance indexes (HbA1c and visceral adiposity index) of hypertensive patients with O/MS associated hypertension before and after 24 weeks of cholecalciferol supplementation. 4.Characterize cardiac index, systemic vascular resistance index and thoracic fluid content in the patients studied before cholecalciferol supplementation. 5.Quantify salt consumption in the diet and correlate with Th17 and T regulatory cells percentage in the patients studied before cholecalciferol supplementation. ;Primary end point(s): Frequency of TCD4+, TCD8+, Th17 and T regulatory cells before and after 24 weeks of cholecalciferol supplemmentation.;Timepoint(s) of evaluation of this end point: The timepoint for evaluation of the defined end point is 24 weeks after the beginning of cholecalciferol supplementation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Frequency of T limphocytes and macrophages in the subcutaneous abdominal adipose tissue before and after 24 weeks cholecalciferol supplementation. - Variation of metabolic profiles (glutamine and glutamate) before and after 24 weeks cholecalciferol supplementation. - Variation of insulin-resistance indexes (HbA1c and visceral adiposity index) before and after 24 weeks cholecalciferol supplementation. ;Timepoint(s) of evaluation of this end point: The timepoint for evaluation of the defined end points is 24 weeks after the beginning of cholecalciferol supplementation. | — |
Countries
Portugal
Contacts
Public ContactErnesto Rocha
Núcleo de Estudos de Hipertensão da Beira Interior
Outcome results
None listed