Role of Aprotinin in Glucagon Degradation, Measurement by Radioimmunoactive Method (RIA) I125
This study has been completed.
Information provided by (Responsible Party):
Mikkel Christensen, University Hospital, Gentofte, Copenhagen
First received: September 8, 2011
Last updated: July 10, 2015
Last verified: July 2015
The aim of the study was to investigate the role of the Trasylol in glucagon prevention in degradation using radioimmunoactive method with I125. Additionally different incubation time was introduced in human plasma samples after oral glucose stimulation, also in fasted and hypoglycemia blood samples from patients' type 2 diabetes. Since, the structure and the techniques for the glucagon measurement are well described nowadays.
Other: Fasting glycemia
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Primary Outcome Measures:
- Change in plasma glucagon values measured with c-terminal specific "micro-protocol" RIA4305: 350µl of plasma (duplicate sample). [ Time Frame: 120 min ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
Other: Fasting glycemia
Insulin induced hypoglycemia
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Caucasians 18 years or older with Type 2 diabetes (WHO criteria)
- HbA1c >9 %
- Liver disease (ALAT/ASAT >2 x upper normal limit)
- Diabetic nephropathy (s-creatinine >130 µM or albuminuria)
- Proliferative diabetic retinopathy (anamnestic)
- Severe arteriosclerosis or heart failure (NYHA group III og IV)
- treatment with medication not applicable to pause for 12 hours
- pregnancy or lactation
- Fasting plasma glucose >15 mM on screening day.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01436734
|Hellerup, Denmark, 2900 |
University Hospital, Gentofte, Copenhagen
||Mikkel Christensen, MD
No publications provided
ClinicalTrials.gov processed this record on August 02, 2015
||Mikkel Christensen, MD, University Hospital, Gentofte, Copenhagen
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 8, 2011
||July 10, 2015
||Denmark: Danish Medicines Agency