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
|