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

Information source: Aristotle University Of Thessaloniki
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Diabetes; Insulin Resistance

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

Phase: Phase 4

Status: Completed

Sponsored by: Aristotle University Of Thessaloniki

Official(s) and/or principal investigator(s):
Anastasios N. Lasaridis, MD, PhD, Principal Investigator, Affiliation: 1st Department of Internal Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Greece
Maria I. Pikilidou, MD, MSc, Study Director, Affiliation: 1st Department of Internal Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Greece

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.

Clinical Details

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

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

Primary outcome: To evaluate the difference in 24h blood pressure measurement and insulin sensitivity between the treatment and the control group.

Secondary outcome:

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.

To evaluate differences in the transmembrane sodium/hydrogen exchanger activity between the active treatment and the control group.

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

AHEPA University Hospital, Thessaloniki 54636, Greece
Additional Information

Starting date: January 2007
Last updated: July 2, 2008

Page last updated: August 20, 2015

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