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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01436734
First Posted: September 20, 2011
Last Update Posted: July 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mikkel Christensen, University Hospital, Gentofte, Copenhagen
  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: None (Open Label)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Mikkel Christensen, 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 ]

Enrollment: 5
Study Start Date: July 2011
Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GIP Other: Fasting glycemia
no intervention
Other: Hypoglycemia
Insulin induced hypoglycemia

  Eligibility

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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.
  Contacts and Locations
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
  More Information

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 Submitted: September 8, 2011
First Posted: September 20, 2011
Last Update Posted: July 14, 2015
Last Verified: July 2015