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

Sponsor:	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

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

Resource links provided by NLM:

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

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 ]

Estimated Enrollment:	12
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (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

No publications provided

Responsible Party:	Vanderbilt University Medical Center ( T. Alp Ikizler, MD )
Study ID Numbers:	080074
Study First Received:	April 4, 2008
Last Updated:	June 17, 2009
ClinicalTrials.gov Identifier:	NCT00656032 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

insulin resistance
end stage renal disease

Additional relevant MeSH terms:

Renal Insufficiency
Metabolic Diseases
Physiological Effects of Drugs
Kidney Failure, Chronic
Pharmacologic Actions
Insulin
Inflammation
Hyperinsulinism

Hypoglycemic Agents
Pathologic Processes
Urologic Diseases
Renal Insufficiency, Chronic
Insulin Resistance
Kidney Diseases
Glucose Metabolism Disorders
Kidney Failure

ClinicalTrials.gov processed this record on November 25, 2009