Status:
COMPLETED
Diabetogenicity of Cyclosporine and Tacrolimus
Lead Sponsor:
University of Aarhus
Conditions:
Complications of Transplanted Organs and Tissue
Diabetes Mellitus Nos New Onset
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 tra...
Detailed Description
Background: Post-transplantation diabetes mellitus (PTDM) is a complication of the calcineurin inhibitors (CI) cyclosporine (CsA) and Tacrolimus (Tac), but much controversy still exists regarding the ...
Eligibility Criteria
Inclusion
- Healthy volunteers (Study 1):
- 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.
- Hemodialysis Patients (study 2):
- Age between 18 years and 70 years. Upper limit can be +2 years if approved by main investigator.
- BMI \< 30 kg/m2. Allowed variations are 5% over the upper limit.
- On the waiting-list for a kidney transplant.
- Haemodialysis candidate.
- Anti-conceptive treatment (contraceptive pill/intrauterine device/patch/ring/ implant/injectable contraceptive) if the patient is a fertile woman.
- Written consent to participate. -
Exclusion
- Healthy volunteers (Study 1):
- Anaemia with haemoglobin levels \< 7 mmol/L
- Participation in any other clinical trial.
- Subjects who cannot adhere to test conditions.
- Anamnesis of clinically significant disease, such as:
- liver disease
- kidney disease,
- neurological disease
- gastrointestinal disease
- haematological disease
- endocrine disease
- lung disease
- cardiac disease
- Drug or alcohol abuse, which would render the subject unfit according to the main investigator.
- Blood donation 1 month prior to the study day
- Patients with established allergy against CI or other medical products, which might pose a risk if they participated in this study.
- Use of prescription drugs within one month prior to the study days, unless they are clinically insignificant according to the main investigator.
- Smoking 8 hours prior to the study day
- Vigorous exercise 30 minutes prior to the study day.
- Hemodialysis Patients (study 2):
- Peritoneal dialysis.
- Anaemia with haemoglobin levels \< 6 mmol/L.
- Participation in any other clinical trial.
- Treatment with corticosteroids, CsA or Tac.
- Patients who cannot adhere to test conditions.
- Patients with established allergy against CI or other medical product, which might pose a risk if they participated in this study.
- Drug or alcohol abuse, which would render the subject unfit according to the main investigator.
- Anamnesis of current diabetes and/or intake of anti-diabetic medication.
- Malignancy.
- Uncontrolled infection.
- Uncontrolled hypertension.
- Smoking 8 hours prior to the study day.
- Vigorous exercise 30 minutes prior to the study day
- \-
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00766909
Start Date
March 1 2008
End Date
November 1 2011
Last Update
November 8 2011
Active Locations (1)
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1
Department of Nephrology, Aarhus University Hospital, Skejby
Aarhus, Jutland, Denmark, 8200