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Vitamin D, Insulin Resistance and Inflammation in ESRD

This study has been completed.
Information provided by (Responsible Party):
Alp Ikizler, Vanderbilt University Identifier:
First received: April 4, 2008
Last updated: January 9, 2012
Last verified: January 2012
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.

Condition Intervention Phase
End Stage Renal Disease Other: paricalcitol Other: cinacalcet Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vitamin D, Insulin Resistance and Inflammation in ESRD

Resource links provided by NLM:

Further study details as provided by Alp Ikizler, Vanderbilt University:

Primary Outcome Measures:
  • An improvement in insulin sensitivity [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • A change in insulin signaling [ Time Frame: 8 weeks ]
  • A decrease in concentration of plasma pro-inflammatory cytokines [ Time Frame: 8 weeks ]

Enrollment: 12
Study Start Date: April 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
SOC medication for treatment of renal osteodystrophy
Other: paricalcitol
1 to 20 micrograms administered via IV; every other day, 3 days per week, for 8 weeks
Other Name: zemplar
Active Comparator: 2
alternate SOC medication for treatment of renal osteodystrophy
Other: cinacalcet
0 to 180 mg administered orally every day for either 8 weeks or 16 weeks
Other Name: sensipar


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00656032

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Alp Ikizler, MD Vanderbilt University Medical Center
  More Information

Responsible Party: Alp Ikizler, Professor, Vanderbilt University Identifier: NCT00656032     History of Changes
Other Study ID Numbers: 080074
Study First Received: April 4, 2008
Last Updated: January 9, 2012

Keywords provided by Alp Ikizler, Vanderbilt University:
insulin resistance
end stage renal disease

Additional relevant MeSH terms:
Insulin Resistance
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Renal Insufficiency
Vitamin D
Cinacalcet Hydrochloride
Hypoglycemic Agents
Physiological Effects of Drugs
Growth Substances
Bone Density Conservation Agents
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on July 19, 2017