The Effect of Calcium Supplementation on Insulin Resistance and 24h Blood Pressure - Full Text View

Purpose

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

U.S. FDA Resources

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

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:

To evaluate the difference in 24h blood pressure measurement and insulin sensitivity between the treatment and the control group. [ Time Frame: baseline and after 8 weeks of follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: baseline and after 8 weeks of follow up ] [ Designated as safety issue: No ]
To evaluate differences in the transmembrane sodium/hydrogen exchanger activity between the active treatment and the control group. [ Time Frame: baseline and after 8 weeks of follow up ] [ Designated as safety issue: No ]

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.
1: Active Comparator Patients on calcium supplementation	Dietary Supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz) 1500 mg of elemental calcium per day.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549536

Locations


Greece
	AHEPA University Hospital
	Thessaloniki, Greece, 54636

Sponsors and Collaborators

Aristotle University Of Thessaloniki

Hellenic Society of Hypertension

Investigators


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

More Information

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

Keywords provided by Aristotle University Of Thessaloniki:

calcium supplementation

intracellular ions

sodium/hydrogen exchange activity

Study placed in the following topic categories:

Hyperinsulinism

Metabolic Diseases

Diabetes Mellitus, Type 2

Vascular Diseases

Diabetes Mellitus

Insulin Resistance

Metabolic disorder

Glucose Metabolism Disorders

Insulin

Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2008

Sponsors and Collaborators:	Aristotle University Of Thessaloniki Hellenic Society of Hypertension
Information provided by:	Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:	NCT00549536