Vitamin D, Insulin Resistance and Inflammation in ESRD

End Stage Renal Disease Clinical Trial

Official title:

Vitamin D, Insulin Resistance and Inflammation in ESRD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656032
• Other study ID #: 080074
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2008
• Last updated: January 9, 2012
• Start date: April 2008
• Est. completion date: January 2010

Study information

• Verified date: January 2012
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Insulin Resistance
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Other:
• paricalcitol
1 to 20 micrograms administered via IV; every other day, 3 days per week, for 8 weeks
• cinacalcet
0 to 180 mg administered orally every day for either 8 weeks or 16 weeks

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	An improvement in insulin sensitivity		8 weeks	No
Secondary	A change in insulin signaling		8 weeks	No
Secondary	A decrease in concentration of plasma pro-inflammatory cytokines		8 weeks	No