Type 2 DiabetesNCT01792206
Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease
A study testing Zemplar in people with Type 2 Diabetes and Chronic Kidney Disease, run by Scott and White Hospital & Clinic at 4 sites in United States.
Trial summary
The purpose of this research study is to study the effects of paricalcitol on endothelial function and inflammation, cardiovascular risk factors which are associated with patient populations that have Type 2 diabetes and Stage 3 and 4 Chronic Kidney Disease (CKD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes, Chronic Kidney Disease
- What is being tested?
- Zemplar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2009to Feb 2013
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Type 2 diabetes and CKD
- Age 18 - 70 years
- Stable anti-hypertensive and lipid lowering therapy for at least 2 months. All patients should be on an ACEI or ARB unless contraindicated because of side effects (standard of care). No changes in lipid lowering therapy during the 3 months of this study. Blood pressure doses may be changed but new therapy with ACE inhibitors will not be allowed.
Who cannot join
- Severe co morbid conditions - e.g. Cancer, etc.
- Congestive heart failure.
- Inability to give informed consent or attend study related visits.
- Have a history of abnormally high vitamin D or calcium levels in the bloodstream.
- Unwilling or unable to complete screening or data collection procedures.
- Have a known allergy to the study drug.
Show all 10Show fewer
- Pregnant or breast feeding
- Plasma Calcium >9 mg/dl
- Patients should discontinue any calcium supplementation prior to entry into the study.
- Other vitamin D analogs (eg Sensipar) and vitamin D preparations are contraindicated
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University
Atlanta, Georgia, 30303
Joslin Diabetes Clinic, Inc.
Boston, Massachusetts, 02215
Tulane University
New Orleans, Louisiana, 70112
Omaha VA Medical Center
Omaha, Nebraska, 68105
About this study
Official title: EFFECT OF PARICALCITOL (ZEMPLAR) ON ENDOTHELIAL FUNCTION AND INFLAMMATION IN TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE
The purpose of this research study is to study the effects of paricalcitol on endothelial function and inflammation, cardiovascular risk factors which are associated with patient populations that have Type 2 diabetes and Stage 3 and 4 Chronic Kidney Disease (CKD).
Hypothesis 1: The state of CKD is associated with oxidative stress and inflammation and impaired post ischemic endothelium dependent flow mediated vasodilation which may contribute to atherogenesis.
Hypothesis 2: The administration of paracalcitol to patients with CKD will suppress oxidative stress and inflammation and improve endothelial function and thus contribute to an anti-atherogenic action.
- Conditions
- Type 2 Diabetes, Chronic Kidney Disease
- Being tested
- Zemplar, Placebo
- Keywords
- Stage 3 chronic kidney disease (CKD), Stage 4 chronic kidney disease (CKD), CKD
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZemplarDrug
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
PlaceboDrug
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Zemplar | Active comparator | Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months Receives: Drug: Zemplar |
| Placebo | Placebo comparator | Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in brachial artery Flow Mediated Dilataion with paracalcitol (1mcg/day)compared with placebo for 3 months.
We therefore propose a study of the effects of Zemplar compared to placebo in patients with diabetes and stage 3-4 CKD on endothelial function and markers of inflammation and oxidative stress. The finding will help not only guide and encourage such treatment in similar patients, but will give us fundamental mechanistic insights into the role of vitamin D in the pathogenesis of diabetes and CVD.
Measured: Baseline, 4 weeks, and 12 weeks
Secondary outcomes (2)
Biomarker Measurement
Determine the prevalance of abnormalities in biomarkers of inflammation, oxidative stress and endothelial function in patients with CKD compared to a healthy population
The following are the biomarkers of inflammation and oxidative stress to be measured in the secondary outcomes are:
NFkB binding by mononuclear cells (MNC) ; ROS generation and p47phox expression by MNC plasma concentration of MMP-9, MCP-1, ICAM-1, IL-6 , CRP, ADMA and nitrotyrosine.. urinary isoprostane and plasma Nitrotyrosine in patients with CKD.
Measured: Baseline, 4 weeks, and 12 weeks
Biomarker Measurement
Compare the change in biomarkers of inflammation, oxidative stress and endothelial function with paracalcitol (1mcg/day) compared with placebo for 3 months in patients with CKD.
The following are the biomarkers of inflammation and oxidative stress to be measured in the secondary outcomes are:
NFkB binding by mononuclear cells (MNC) ; ROS generation and p47phox expression by MNC plasma concentration of MMP-9, MCP-1, ICAM-1, IL-6 , CRP, ADMA and nitrotyrosine.. urinary isoprostane and plasma Nitrotyrosine in patients with CKD.
Measured: Baseline, 4 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startSep 2009
- Primary completionNov 2012
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scott and White Hospital & Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Vasudevan Raghavan, Scott and White Hospital & Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792206
- Sponsor's protocol ID
- 81890
- Status last verified
- Feb 2013
- First submitted
- 29 Feb 2012
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF PARICALCITOL (ZEMPLAR) ON ENDOTHELIAL FUNCTION AND INFLAMMATION IN TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE
- ClinicalTrials.gov ID
- NCT01792206
- Acronym / sponsor ID
- 81890
- Conditions
- Type 2 Diabetes, Chronic Kidney Disease
- Keywords
- Stage 3 chronic kidney disease (CKD), Stage 4 chronic kidney disease (CKD), CKD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Scott and White Hospital & ClinicUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Sep 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Feb 2013 (estimated)
- First posted
- 15 Feb 2013 (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.
The purpose of this research study is to study the effects of paricalcitol on endothelial function and inflammation, cardiovascular risk factors which are associated with patient populations that have Type 2 diabetes and Stage 3 and 4 Chronic Kidney Disease (CKD).
Hypothesis 1: The state of CKD is associated with oxidative stress and inflammation and impaired post ischemic endothelium dependent flow mediated vasodilation which may contribute to atherogenesis.
Hypothesis 2: The administration of paracalcitol to patients with CKD will suppress oxidative stress and inflammation and improve endothelial function and thus contribute to an anti-atherogenic action.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zemplar | Active comparator | Drug: ZemplarZemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months |
| Placebo | Placebo comparator | Drug: PlaceboZemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Type 2 diabetes and CKD
- Age 18 - 70 years
- Stable anti-hypertensive and lipid lowering therapy for at least 2 months. All patients should be on an ACEI or ARB unless contraindicated because of side effects (standard of care). No changes in lipid lowering therapy during the 3 months of this study. Blood pressure doses may be changed but new therapy with ACE inhibitors will not be allowed.
Key exclusion criteria (10 listed)
- Severe co morbid conditions - e.g. Cancer, etc.
- Congestive heart failure.
- Inability to give informed consent or attend study related visits.
- Have a history of abnormally high vitamin D or calcium levels in the bloodstream.
- Unwilling or unable to complete screening or data collection procedures.
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 |
|---|---|---|
| ZemplarZemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months | Drug | Zemplar |
| PlaceboZemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months | Drug | Placebo |
Primary outcome
The change in brachial artery Flow Mediated Dilataion with paracalcitol (1mcg/day)compared with placebo for 3 months.
Time frame: Baseline, 4 weeks, and 12 weeks
We therefore propose a study of the effects of Zemplar compared to placebo in patients with diabetes and stage 3-4 CKD on endothelial function and markers of inflammation and oxidative stress. The finding will help not only guide and encourage such treatment in similar patients, but will give us fundamental mechanistic insights into the role of vitamin D in the pathogenesis of diabetes and CVD.
2 secondary outcomes
Biomarker Measurement
Time frame: Baseline, 4 weeks, and 12 weeks
Biomarker Measurement
Time frame: Baseline, 4 weeks, and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zemplar in people with Type 2 Diabetes and Chronic Kidney Disease, run by Scott and White Hospital & Clinic at 4 sites in United States.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
The change in brachial artery Flow Mediated Dilataion with paracalcitol (1mcg/day)compared with placebo for 3 months. (time frame: Baseline, 4 weeks, and 12 weeks). 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 15 Feb 2013.