Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Type 2 Diabetes, Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT01792206

Run by

Scott and White Hospital & Clinic

People needed

60

Starts

2009-09-01

Expected to finish

2013-02-01

Last updated by the study team

2013-02-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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

Where it is running

• Emory University — Atlanta, Georgia, United States
• Tulane University — New Orleans, Louisiana, United States
• Joslin Diabetes Clinic, Inc. — Boston, Massachusetts, United States
• Omaha VA Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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