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Vitamin D, Insulin Resistance and Inflammation in ESRD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alp Ikizler, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00656032
First received: April 4, 2008
Last updated: January 9, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • An improvement in insulin sensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A change in insulin signaling [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • A decrease in concentration of plasma pro-inflammatory cytokines [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656032

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

No publications provided

Responsible Party: Alp Ikizler, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00656032     History of Changes
Other Study ID Numbers: 080074
Study First Received: April 4, 2008
Last Updated: January 9, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Inflammation
Insulin Resistance
Kidney Diseases
Kidney Failure, Chronic
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
 Renal Insufficiency
Vitamin D
Vitamins
Insulin
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Hypoglycemic Agents

ClinicalTrials.gov processed this record on June 17, 2013