Vitamin D, Insulin Resistance and Inflammation in ESRD - Full Text View

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00656032

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	Drug: paricalcitol Drug: cinacalcet	Phase II

Drug Information available for: Insulin Vitamin D Ergocalciferol Cinacalcet Cinacalcet hydrochloride 19-Nor-1alpha,25-dihydroxyvitamin D2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Vitamin D, Insulin Resistance and Inflammation in ESRD

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 ]

Estimated Enrollment:	12
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: paricalcitol 1 to 20 micrograms administered via IV; every other day, 3 days per week, for 8 weeks
2: Active Comparator	Drug: cinacalcet 0 to 180 mg administered orally every day for either 8 weeks or 16 weeks

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

Contacts

Contact: Mary Sundell

615-322-4698

mary.b.sundell@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt University Medical Center	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Mary Sundell 615-322-4698 mary.b.sundell@vanderbilt.edu
Principal Investigator: Alp Ikizler, MD

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Alp Ikizler, MD

Vanderbilt University

More Information

Responsible Party:	Vanderbilt University Medical Center ( T. Alp Ikizler, MD )
Study ID Numbers:	080074
Study First Received:	April 4, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00656032
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

insulin resistance
end stage renal disease

Study placed in the following topic categories:

Renal Insufficiency
Metabolic Diseases
Kidney Failure, Chronic
Ergocalciferols
Insulin
Inflammation
Hyperinsulinism
Vitamin D

Urologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Insulin Resistance
Glucose Metabolism Disorders
Metabolic disorder
Kidney Failure

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009