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

July 2, 2008 updated by: Aristotle University Of Thessaloniki

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54636
        • Ahepa University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: 2
Dietary supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)
1500 mg of elemental calcium per day.
Other Names:
  • Mega-Calcium Sandoz
ACTIVE_COMPARATOR: 1
Patients on calcium supplementation
Dietary supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)
1500 mg of elemental calcium per day.
Other Names:
  • Mega-Calcium Sandoz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
baseline and after 8 weeks of follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
baseline and after 8 weeks of follow up
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
baseline and after 8 weeks of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ACTUAL)

May 1, 2008

Study Registration Dates

First Submitted

October 25, 2007

First Submitted That Met QC Criteria

October 25, 2007

First Posted (ESTIMATE)

October 26, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 4, 2008

Last Update Submitted That Met QC Criteria

July 2, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3242

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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