Role of Aprotinin in Glucagon Degradation, Measurement by Radioimmunoactive Method (RIA) I125
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by University Hospital, Gentofte, Copenhagen.
Recruitment status was Active, not recruiting
Information provided by (Responsible Party):
Mikkel Christensen, University Hospital, Gentofte, Copenhagen
First received: September 8, 2011
Last updated: November 17, 2012
Last verified: November 2012
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:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
|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 May 27, 2015
||Mikkel Christensen, MD, University Hospital, Gentofte, Copenhagen
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 8, 2011
||November 17, 2012
||Denmark: Danish Medicines Agency