NCT00549536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

July 4, 2008

Status Verified

June 1, 2008

Enrollment Period

1.3 years

First QC Date

October 25, 2007

Last Update Submit

July 2, 2008

Conditions

HypertensionDiabetesInsulin Resistance

Keywords

calcium supplementationintracellular ionssodium/hydrogen exchange activity

Outcome Measures

Primary Outcomes (1)

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

    baseline and after 8 weeks of follow up

Secondary Outcomes (2)

  • 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.

    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.

    baseline and after 8 weeks of follow up

Study Arms (2)

2

NO INTERVENTION
Dietary Supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)

1

ACTIVE COMPARATOR

Patients on calcium supplementation

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

Interventions

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

1500 mg of elemental calcium per day.

Also known as: Mega-Calcium Sandoz
12

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AHEPA University Hospital

Thessaloniki, 54636, Greece

Location

MeSH Terms

Conditions

HypertensionDiabetes MellitusInsulin Resistance

Interventions

Calcium

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Anastasios N. Lasaridis, MD, PhD

    1st Department of Internal Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Greece

    PRINCIPAL INVESTIGATOR

  • Maria I. Pikilidou, MD, MSc

    1st Department of Internal Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Greece

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2007

First Posted

October 26, 2007

Study Start

January 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

July 4, 2008

Record last verified: 2008-06

Locations

GR(1)