Vitamin D, Insulin Resistance and Inflammation in ESRD

Phase 2

Completed

• Conditions: End Stage Renal Disease
• Interventions: Other: paricalcitol; Other: cinacalcet

• Registration Number: NCT00656032
• Lead Sponsor: Vanderbilt University

Brief Summary

The broad goal of this study is to understand the mechanisms by which Vitamin D receptor activation leads to changes in insulin signaling in advanced uremia. We hypothesize that 1,25-Dihydroxyvitamin D3 deficiency due to advanced chronic kidney disease leads to insulin resistance and that administration of a vitamin D3 analog will restore insulin sensitivity in End Stage Renal Disease patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-10
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-09
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• CKD and receiving hemodialysis for ≥ 3months
• Kt/V ≥ 1.2
• ≥ 18 years of age
• Medically stable
• AVF or PTFE dialysis access
• No acute inflammatory disease within 4 weeks prior to the study
• On stable dose of Paricalcitol for 4 weeks prior to the study
• iPTH value between 150 - 1500 within the past 3 months
• Ca < 10.5
• PO4 < 10

Exclusion Criteria

• Pregnancy
• Intolerance to the study medication
• Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease)
• Type 1 Diabetes mellitus
• Uncontrolled Type 2 Diabetes mellitus (HbA1c > 10)
• Hospitalization within 1 month prior to the study
• Malfunctioning arterial-venous vascular access (recirculation and/or blood flow < 250 ml/min)
• Presence of hemodialysis catheter
• Patients receiving steroids and/or other immunosuppressive agents (> 10 mg prednisone qd)
• BMI < 25 and > 45

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	paricalcitol	SOC medication for treatment of renal osteodystrophy
2	cinacalcet	alternate SOC medication for treatment of renal osteodystrophy

Primary Outcome Measures

Name	Time	Method
An improvement in insulin sensitivity	8 weeks

Secondary Outcome Measures

Name	Time	Method
A change in insulin signaling	8 weeks
A decrease in concentration of plasma pro-inflammatory cytokines	8 weeks

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States