Role of Aprotinin in Glucagon Degradation, Measurement by Radioimmunoactive Method (RIA) I125

Hyperglucagonemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436734
• Other study ID #: H-D-2009-0078
• Status: Completed
• Phase: N/A
• First received: September 8, 2011
• Last updated: July 10, 2015
• Start date: July 2011
• Est. completion date: May 2013

Study information

• Verified date: July 2015
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Caucasians 18 years or older with Type 2 diabetes (WHO criteria)

Exclusion 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)

• Anemia

• treatment with medication not applicable to pause for 12 hours

• pregnancy or lactation

• Fasting plasma glucose >15 mM on screening day.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hyperglucagonemia

Intervention

Other:
• Fasting glycemia
no intervention
• Hypoglycemia
Insulin induced hypoglycemia

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma glucagon values measured with c-terminal specific "micro-protocol" RIA4305: 350µl of plasma (duplicate sample).		120 min	No