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

Sponsor:	Vanderbilt University
Information provided by (Responsible Party):	Alp Ikizler, 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	Other: paricalcitol Other: cinacalcet	Phase II

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:

MedlinePlus related topics: Diabetes Medicines Kidney Failure Vitamin D

Drug Information available for: Insulin Insulin beef 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 ]

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 February 12, 2012