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

Phase 4

Completed

• Conditions: Hypertension; Diabetes; Insulin Resistance
• Interventions: Dietary Supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)

• Registration Number: NCT00549536
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-10-25
• Study First Submitted QC: 2007-10-25
• Study First Posted: 2007-10-26
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2008-06
• Last Update Submitted: 2008-07-02
• Last Update Posted: 2008-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)	-
1	tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)	Patients on calcium supplementation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

AHEPA University Hospital; 🇬🇷 Thessaloniki, Greece