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

NCT ID: NCT00549536

Last Updated: 2008-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-05-31

Brief Summary

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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

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Conditions

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Hypertension Diabetes Insulin Resistance

Keywords

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calcium supplementation intracellular ions sodium/hydrogen exchange activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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2

Group Type NO_INTERVENTION

tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)

Intervention Type DIETARY_SUPPLEMENT

1500 mg of elemental calcium per day.

1

Patients on calcium supplementation

Group Type ACTIVE_COMPARATOR

tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)

Intervention Type DIETARY_SUPPLEMENT

1500 mg of elemental calcium per day.

Interventions

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tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)

1500 mg of elemental calcium per day.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Mega-Calcium Sandoz

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hellenic Society of Hypertension

OTHER

Sponsor Role collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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1st Department of medicine AHEPA University Hospital

Principal Investigators

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Anastasios N. Lasaridis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

1st Department of Internal Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Greece

Maria I. Pikilidou, MD, MSc

Role: STUDY_DIRECTOR

1st Department of Internal Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Greece

Locations

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AHEPA University Hospital

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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A3242

Identifier Type: -

Identifier Source: org_study_id