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Diabetogenicity of Cyclosporine and Tacrolimus

NCT00766909 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2011-11-08

No results posted yet for this study

Summary

Cyclosporine (CsA) and Tacrolimus (Tac) are immunosuppressive agents comprising the cornerstone of treatment among organ transplant recipients. Unfortunately diabetes is a known complication after transplantation, yet the underlying mechanisms of this type of diabetes are still unresolved. A direct comparison of the diabetogenic effects of CsA and Tac, without interference of corticosteroid treatment, has not yet been investigated using a hyperinsulinemic euglycemic glucose clamp technique, which is the best method for estimating insulin sensitivity.

Randomized, investigator-blinded cross-over studies will be carried out, studying 10 healthy subjects and 10 hemodialysis patients. Each participant will receive treatment with CsA, Tac and placebo respectively in a random order. The results will be of relevance to the choice and monitoring of immunosuppressive regimens in kidney transplant recipients as well as the development of better treatment modalities for diabetes.

Conditions

  • Complications of Transplanted Organs and Tissue
  • Diabetes Mellitus Nos New Onset

Interventions

DRUG

cyclosporine

For Healthy volunteers (study 1) and Dialysis patients (study 2): Single intravenous infusion of 0.155 mg/kg over a maximum duration of 5 hours. For Dialysis Patients (study 2): Oral intake of 4 mg/kg 2 times daily for 8-11 days.

DRUG

tacrolimus

For Healthy volunteers (study 1) and Dialysis patients (study 2): Single intravenous infusion of 0.0012 mg/kg over a maximum duration of 5 hours. For Dialysis Patients (study 2): Oral intake of 0.1 mg/kg 2 times daily for 8-11 days.

OTHER

Capsules and isotonic saline

For Healthy volunteers (study 1) and Dialysis patients (study 2): Single intravenous infusion of 0.06 ml/kg isotonic saline over a maximum duration of 5 hours. For Dialysis patients (study 2): Placebo capsules 2 times daily for 8-11 days.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Lara Aygen Øzbay, MD · Aarhus University Hospital Skejby

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-06-30
Completion
2011-11-30

Countries

  • Denmark

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00766909 on ClinicalTrials.gov