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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mikkel Christensen, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01436734
First received: September 8, 2011
Last updated: November 17, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Hyperglucagonemia
 Other: Fasting glycemia
Other: Hypoglycemia

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

MedlinePlus related topics: Hypoglycemia
U.S. FDA Resources

Further study details as provided by University Hospital, Gentofte, Copenhagen:

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 ]

Enrollment: 5
Study Start Date: July 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Fasting glycemia
    no intervention
    Other: Hypoglycemia
    Insulin induced hypoglycemia
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436734

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

No publications provided

Responsible Party: Mikkel Christensen, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01436734     History of Changes
Other Study ID Numbers: H-D-2009-0078
Study First Received: September 8, 2011
Last Updated: November 17, 2012
Health Authority: Denmark: Danish Medicines Agency

ClinicalTrials.gov processed this record on May 16, 2013