Diabetes, Hypertension, Insulin Resistance
Conditions
Keywords
calcium supplementation, intracellular ions, sodium/hydrogen exchange activity
Brief summary
Increased levels of intracellular calcium are thought to diminish maximal cellular response to insulin and induce insulin resistance. Also, both hypertension and diabetes are thought to be conditions of altered intracellular ionic state. The aim of the present study is to investigate the possible effect of oral calcium supplementation on intracellular ions, insulin sensitivity, 24-h blood pressure and sodium/hydrogen exchanger activity in patients with type 2 diabetes and essential hypertension.
Interventions
DIETARY_SUPPLEMENTtablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)
1500 mg of elemental calcium per day.
Sponsors
Hellenic Society of Hypertension
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients with hypertension, diabetes and the metabolic syndrome (according to the definition of the National Cholesterol Education Program, Adult Panel III (NCEP, ATP III). * Signed the concent form
Exclusion criteria
* Secondary Hypertension * Stage II or III hypertension * History of renal disease * Sleep apnea * Acute or chronic inflammation * History of coronary artery disease * Heart failure stage III or IV according to the New York Heart Association * Active liver disease * History of malignancy * Parathyroidism * History of kidney stones * Calcium supplement ingestion * Drugs that alter insulin resistance * Treatment with insulin * Alcohol abuse or other conditions with poor prognosis * Treatment with non-inflammatory steroid agents, corticosteroids, or any other treatment that affects blood pressure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the difference in 24h blood pressure measurement and insulin sensitivity between the treatment and the control group. | baseline and after 8 weeks of follow up |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate differences in intracellular calcium, magnesium, sodium and potassium concentrations at the end of the follow up period between the calcium supplementation group and the control group. | baseline and after 8 weeks of follow up |
| To evaluate differences in the transmembrane sodium/hydrogen exchanger activity between the active treatment and the control group. | baseline and after 8 weeks of follow up |
Countries
Greece
Outcome results
None listed