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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Hypoglycemic Agents

ClinicalTrials.gov processed this record on September 14, 2014