Vitamin D, Insulin Resistance and Inflammation in ESRD

NCT00656032 | Completed Phase 2

• 1 other identifier: 080074
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Renal Disease

Keywords

insulin resistance; end stage renal disease

Outcome Measures

Primary Outcomes (1)

• An improvement in insulin sensitivity

  8 weeks

Secondary Outcomes (2)

• A change in insulin signaling

  8 weeks

• A decrease in concentration of plasma pro-inflammatory cytokines

  8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

SOC medication for treatment of renal osteodystrophy

Other: paricalcitol

2

ACTIVE COMPARATOR

alternate SOC medication for treatment of renal osteodystrophy

Other: cinacalcet

Interventions

paricalcitol OTHER

1 to 20 micrograms administered via IV; every other day, 3 days per week, for 8 weeks

Also known as: zemplar

1

cinacalcet OTHER

0 to 180 mg administered orally every day for either 8 weeks or 16 weeks

Also known as: sensipar

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Insulin Resistance

Interventions

paricalcitol; Cinacalcet

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Alp Ikizler, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 10, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 11, 2012

Record last verified: 2012-01

Locations

US (1)