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

This study has been completed.
Sponsor:
Collaborator:
Hellenic Society of Hypertension
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00549536
First received: October 25, 2007
Last updated: July 2, 2008
Last verified: June 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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
No Intervention: 2 Dietary Supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)
1500 mg of elemental calcium per day.
Other Name: 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 Name: Mega-Calcium Sandoz

  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

No publications provided

Responsible Party: Lasaridis Anastasios, 1st Department of medicine AHEPA University Hospital
ClinicalTrials.gov Identifier: NCT00549536     History of Changes
Other Study ID Numbers: A3242
Study First Received: October 25, 2007
Last Updated: July 2, 2008
Health Authority: Greece: Ethics Committee

Keywords provided by Aristotle University Of Thessaloniki:
calcium supplementation
intracellular ions
sodium/hydrogen exchange activity

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
 Cardiovascular Diseases
Hyperinsulinism
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013