Vitamin D, Insulin Resistance and Inflammation in ESRD

Study Overview
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Brief Summary
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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.

Official Title
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Vitamin D, Insulin Resistance and Inflammation in ESRD

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Other: paricalcitol
* Other: cinacalcet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>SOC medication for treatment of renal osteodystrophy | Other: paricalcitol<br>* 1 to 20 micrograms administered via IV; every other day, 3 days per week, for 8 weeks<br>* Other names: zemplar;|
| Active Comparator: 2<br>alternate SOC medication for treatment of renal osteodystrophy | Other: cinacalcet<br>* 0 to 180 mg administered orally every day for either 8 weeks or 16 weeks<br>* Other names: sensipar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An improvement in insulin sensitivity |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change in insulin signaling |  | 8 weeks | 
| A decrease in concentration of plasma pro-inflammatory cytokines |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin resistance, end stage renal disease