Diabetogenicity of Cyclosporine and Tacrolimus (NCT00766909) | Clinical Trial Compass
CompletedPhase 4
Diabetogenicity of Cyclosporine and Tacrolimus
Denmark18 participantsStarted 2008-03
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Men.
✓. Age between 18 years and 50 years. Upper limit can be +2 years if approved by main investigator.
✓. Normal OGTT (0 and 120 min test).
✓. Body mass index (BMI) 20 - 30 kg/m2. Allowed variations are 5% from the upper and lower limit.
✓. Normal serum creatinine and ionisized calcium. Allowed variations are 20% from the upper and lower limit of the normal value for creatinine and 5% for calcium.
✓. Normal urine stix
✓. Written consent to participate.
✓. Age between 18 years and 70 years. Upper limit can be +2 years if approved by main investigator.
Exclusion criteria
✕. Anaemia with haemoglobin levels \< 7 mmol/L
✕. Participation in any other clinical trial.
What they're measuring
1
Insulin Sensitivity
Timeframe: Serial measurements during 120 minute Hyperinsulinemic euglycemic clamp investigation. Performed 3 times on 3 individual days within 4 months after inclusion