search
Back to results

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

Primary Purpose

Hypertension, Diabetes, Insulin Resistance

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring calcium supplementation, intracellular ions, sodium/hydrogen exchange activity

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AHEPA University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

2

1

Arm Description

Patients on calcium supplementation

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
October 25, 2007
Last Updated
July 2, 2008
Sponsor
Aristotle University Of Thessaloniki
Collaborators
Hellenic Society of Hypertension
search

1. Study Identification

Unique Protocol Identification Number
NCT00549536
Brief Title
The Effect of Calcium Supplementation on Insulin Resistance and 24h Blood Pressure
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 Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aristotle University Of Thessaloniki
Collaborators
Hellenic Society of Hypertension

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes, Insulin Resistance
Keywords
calcium supplementation, intracellular ions, sodium/hydrogen exchange activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
No Intervention
Arm Title
1
Arm Type
Active Comparator
Arm Description
Patients on calcium supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)
Other Intervention Name(s)
Mega-Calcium Sandoz
Intervention Description
1500 mg of elemental calcium per day.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anastasios N. Lasaridis, MD, PhD
Organizational Affiliation
1st Department of Internal Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Greece
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria I. Pikilidou, MD, MSc
Organizational Affiliation
1st Department of Internal Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Greece
Official's Role
Study Director
Facility Information:
Facility Name
AHEPA University Hospital
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs