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Completed

NCT Number: NCT00656032

Vitamin D, Insulin Resistance and Inflammation in ESRD

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paricalcitol

Other

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

Other names: zemplar

cinacalcet

Other

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

Other names: sensipar

Primary outcomes

  1. An improvement in insulin sensitivity

    Time frame: 8 weeks

Secondary outcomes

  1. A change in insulin signaling

    Time frame: 8 weeks

  2. A decrease in concentration of plasma pro-inflammatory cytokines

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 10, 2008
Registry last updated
Jan 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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