HypertensionPhase 4NCT00549536
The Effect of Calcium Supplementation on Insulin Resistance and 24h Blood Pressure
A Phase 4 study testing tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz) in people with Hypertension and Diabetes, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension, Diabetes, Insulin Resistance
- What is being tested?
- tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2007to May 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Secondary Hypertension
- Stage II or III hypertension
- History of renal disease
- Sleep apnea
- Acute or chronic inflammation
- History of coronary artery disease
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Hypertension, Diabetes, Insulin Resistance
- Being tested
- tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)
- Keywords
- calcium supplementation, intracellular ions, sodium/hydrogen exchange activity
- Medical subject headings
- Hypertension, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)Dietary supplement
Also called Mega-Calcium Sandoz
1500 mg of elemental calcium per day.
| Study group | Role | What they receive |
|---|---|---|
| 2 | No intervention | Not described Receives: Dietary Supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz) |
| 1 | Active comparator | Patients on calcium supplementation Receives: Dietary Supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the difference in 24h blood pressure measurement and insulin sensitivity between the treatment and the control group.
Measured: 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.
Measured: 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.
Measured: baseline and after 8 weeks of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startJan 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Hellenic Society of Hypertension
- Investigators
- Anastasios N. Lasaridis, MD, PhD, Principal investigator, 1st Department of Internal Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, GreeceMaria I. Pikilidou, MD, MSc, Study director, 1st Department of Internal Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549536
- Sponsor's protocol ID
- A3242
- Status last verified
- Jun 2008
- First submitted
- 25 Oct 2007
- Last updated
- 4 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00549536
- Acronym / sponsor ID
- A3242
- Conditions
- Hypertension, Diabetes, Insulin Resistance
- Keywords
- calcium supplementation, intracellular ions, sodium/hydrogen exchange activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Hellenic Society of Hypertension
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 26 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | No intervention | Dietary Supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz) |
| 1 | Active comparator | Dietary Supplement: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)Patients on calcium supplementation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (16 listed)
- Secondary Hypertension
- Stage II or III hypertension
- History of renal disease
- Sleep apnea
- Acute or chronic inflammation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)Also: Mega-Calcium Sandoz1500 mg of elemental calcium per day. | Dietary supplement | 1, 2 |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anastasios N. Lasaridis, MD, PhD principal investigator
1st Department of Internal Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Greece
Maria I. Pikilidou, MD, MSc study director
1st Department of Internal Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz) in people with Hypertension and Diabetes, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2008.