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

Scott and White Hospital & Clinic

Status: Unknown

Conditions: Chronic Kidney Disease; Type 2 Diabetes

Treatments: Drug: Zemplar; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01792206

81890

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups, including a placebo group

Zemplar

Active Comparator group

Description:

Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months

Treatment:

Drug: Zemplar

Placebo

Placebo Comparator group

Description:

Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months

Treatment:

Drug: Placebo