Overview

This trial is active, not recruiting.

Conditions type 2 diabetes, chronic kidney disease
Treatments zemplar, placebo
Sponsor Scott and White Hospital & Clinic
Collaborator Abbott
Start date September 2009
End date November 2012
Trial size 60 participants
Trial identifier NCT01792206, 81890

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).

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose diagnostic
Arm
(Active Comparator)
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
zemplar
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
(Placebo Comparator)
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
placebo
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months

Primary Outcomes

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

Secondary Outcomes

Measure
Biomarker Measurement
time frame: Baseline, 4 weeks, and 12 weeks
Biomarker Measurement
time frame: Baseline, 4 weeks, and 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: 1. Patients with Type 2 diabetes and CKD 2. Age 18 - 70 years 3. 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. Exclusion Criteria: 1. Severe co morbid conditions - e.g. Cancer, etc. 2. Congestive heart failure. 3. Inability to give informed consent or attend study related visits. 4. Have a history of abnormally high vitamin D or calcium levels in the bloodstream. 5. Unwilling or unable to complete screening or data collection procedures. 6. Have a known allergy to the study drug. 7. Pregnant or breast feeding 8. Plasma Calcium >9 mg/dl 9. Patients should discontinue any calcium supplementation prior to entry into the study. 10. Other vitamin D analogs (eg Sensipar) and vitamin D preparations are contraindicated

Additional Information

Official title EFFECT OF PARICALCITOL (ZEMPLAR) ON ENDOTHELIAL FUNCTION AND INFLAMMATION IN TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Scott and White Hospital & Clinic.