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

NCT01792206 | Unknown

• 1 other identifier: 81890
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Type 2 Diabetes; Chronic Kidney Disease

Keywords

Stage 3 chronic kidney disease (CKD); Stage 4 chronic kidney disease (CKD); CKD

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 4 weeks, and 12 weeks

Secondary Outcomes (2)

• Biomarker Measurement

  Baseline, 4 weeks, and 12 weeks

• Biomarker Measurement

  Baseline, 4 weeks, and 12 weeks

Study Arms (2)

Zemplar

ACTIVE COMPARATOR

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

Drug: Zemplar

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Zemplar DRUG

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

Zemplar

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Scott and White Hospital & Clinic: lead
• Abbott: collaborator

Study Sites (4)

Emory University

Atlanta, Georgia, 30303, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Joslin Diabetes Clinic, Inc.

Boston, Massachusetts, 02215, United States

Location

Omaha VA Medical Center

Omaha, Nebraska, 68105, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, CArdioMEtabolic, Lipid Clinic and Medical Weight Management Program Services

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: February 15, 2013
• Study Start: September 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: February 1, 2013
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

US (4)