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

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ClinicalTrials.gov Identifier: NCT01436734
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : July 14, 2015
Sponsor:
Information provided by (Responsible Party):
Mikkel Christensen, University Hospital, Gentofte, Copenhagen

Brief 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.

Condition or disease Intervention/treatment
Hyperglucagonemia Other: Fasting glycemia Other: Hypoglycemia

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : July 2011
Primary Completion Date : December 2012
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: GIP Other: Fasting glycemia
no intervention
Other: Hypoglycemia
Insulin induced hypoglycemia



Primary Outcome Measures :
  1. Change in plasma glucagon values measured with c-terminal specific "micro-protocol" RIA4305: 350µl of plasma (duplicate sample). [ Time Frame: 120 min ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436734


Locations
Denmark
Gentofte Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Mikkel Christensen, MD Gentofte Hospital

Responsible Party: Mikkel Christensen, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01436734     History of Changes
Other Study ID Numbers: H-D-2009-0078
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015