| Trial ID: | L6300 |
| Source ID: | NCT00766909
|
| Associated Drug: |
Cyclosporine
|
| Title: |
Diabetogenicity of Cyclosporine and Tacrolimus
|
| Acronym: |
CSATAC
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Complications of Transplanted Organs and Tissue|Diabetes Mellitus Nos New Onset
|
| Interventions: |
DRUG: cyclosporine|DRUG: tacrolimus|OTHER: Capsules and isotonic saline
|
| Outcome Measures: |
Primary: Insulin Sensitivity, Serial measurements during 120 minute Hyperinsulinemic euglycemic clamp investigation. Performed 3 times on 3 individual days within 4 months after inclusion | Secondary: insulin secretion, Serial measurements during IVGTT. Performed 3 times on 3 individual days within 4 months after inclusion.|serum free fatty acids, Serial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.|serum C-peptide, erial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.|blood cyclosporine, erial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.|blood tacrolimus, Serial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.|respiratory gas exchange, substrate metabolism, Indirect calorimetry performed 3 times on 3 individual days within 4 months after inclusion.|Pulsatile Insulin secretion, erial measurements during glucose entrainment. Performed 3 times on 3 individual days within 4 months after inclusion.|plasma Glucose, erial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.|plasma glucagon, erial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.
|
| Sponsor/Collaborators: |
Sponsor: University of Aarhus
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
18
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-03
|
| Completion Date: |
2011-11
|
| Results First Posted: |
|
| Last Update Posted: |
2011-11-08
|
| Locations: |
Department of Nephrology, Aarhus University Hospital, Skejby, Aarhus, Jutland, 8200, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT00766909
|
