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Sponsors and Collaborators: |
Aristotle University Of Thessaloniki Hellenic Society of Hypertension |
Information provided by: | Aristotle University Of Thessaloniki |
ClinicalTrials.gov Identifier: | NCT00549536 |
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.
Condition | Intervention | Phase |
Hypertension Diabetes Insulin Resistance |
Dietary Supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz) |
Phase IV |
MedlinePlus related topics: | Diabetes High Blood Pressure |
ChemIDplus related topics: | Insulin Calcium gluconate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Enrollment: | 31 |
Study Start Date: | January 2007 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
2: No Intervention |
Dietary Supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)
1500 mg of elemental calcium per day.
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1: Active Comparator
Patients on calcium supplementation
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Dietary Supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)
1500 mg of elemental calcium per day.
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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Greece | |||||
AHEPA University Hospital | |||||
Thessaloniki, Greece, 54636 |
Aristotle University Of Thessaloniki |
Hellenic Society of Hypertension |
Principal Investigator: | Anastasios N. Lasaridis, MD, PhD | 1st Department of Internal Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Greece |
Study Director: | Maria I. Pikilidou, MD, MSc | 1st Department of Internal Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Greece |
Responsible Party: | 1st Department of medicine AHEPA University Hospital ( Lasaridis Anastasios ) |
Study ID Numbers: | A3242 |
First Received: | October 25, 2007 |
Last Updated: | July 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00549536 |
Health Authority: | Greece: Ethics Committee |
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