The Effect of Calcium Supplementation on Insulin Resistance and 24h Blood Pressure

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Oral Calcium Supplementation on Insulin Sensitivity, Intracellular Cationic Concentrations and the Transmembrane Sodium/Hydrogen Exchanger Activity in Subjects With Type 2 Diabetes and Hypertension

Conditions
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Hypertension, Diabetes, Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 2<br> | Dietary Supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)<br>* 1500 mg of elemental calcium per day.<br>* Other names: Mega-Calcium Sandoz;|
| Active Comparator: 1<br>Patients on calcium supplementation | Dietary Supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)<br>* 1500 mg of elemental calcium per day.<br>* Other names: Mega-Calcium Sandoz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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calcium supplementation, intracellular ions, sodium/hydrogen exchange activity