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Vitamin D, Insulin Resistance and Inflammation in ESRD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00656032
Recruitment Status : Completed
First Posted : April 10, 2008
Last Update Posted : January 11, 2012
Information provided by (Responsible Party):
Alp Ikizler, 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Other: paricalcitol Other: cinacalcet Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vitamin D, Insulin Resistance and Inflammation in ESRD
Study Start Date : April 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00656032

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

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Responsible Party: Alp Ikizler, Professor, Vanderbilt University Identifier: NCT00656032    
Other Study ID Numbers: 080074
First Posted: April 10, 2008    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: January 2012
Keywords provided by Alp Ikizler, Vanderbilt University:
insulin resistance
end stage renal disease
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Insulin Resistance
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Vitamin D
Hypoglycemic Agents
Physiological Effects of Drugs
Growth Substances
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists