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

A

Aristotle University Of Thessaloniki

Status and phase

Completed
Phase 4

Conditions

Hypertension
Diabetes
Insulin Resistance

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

31 participants in 2 patient groups

2
No Intervention group
Treatment:
Dietary Supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)
1
Active Comparator group
Description:
Patients on calcium supplementation
Treatment:
Dietary Supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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