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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549536
• Other study ID #: A3242
• Status: Completed
• Phase: Phase 4
• First received: October 25, 2007
• Last updated: July 2, 2008
• Start date: January 2007
• Est. completion date: May 2008

Study information

• Verified date: June 2008
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Insulin Resistance

Intervention

Dietary Supplement:
• tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)
1500 mg of elemental calcium per day.

Locations

Country	Name	City	State
Greece	AHEPA University Hospital	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	Hellenic Society of Hypertension

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No