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Completed

NCT Number: NCT00549536

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AHEPA University Hospital

Thessaloniki, 54636, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

1500 mg of elemental calcium per day.

Other names: Mega-Calcium Sandoz

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • Hellenic Society of Hypertension

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 26, 2007
Registry last updated
Jul 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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