Physiologic Response to Glucagon at Varying Insulin Levels

This study has been completed.
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Oregon Health and Science University
Information provided by (Responsible Party):
W. Kenneth Ward, Legacy Health System
ClinicalTrials.gov Identifier:
NCT01483651
First received: November 29, 2011
Last updated: September 17, 2014
Last verified: September 2014
Results First Received: September 8, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Basic Science
Condition: Type 1 Diabetes Mellitus
Interventions: Drug: Glucagon
Drug: Regular insulin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Study Participants Eight subjects completed all study visits, having underwent a study visit with: 1) low, 2) medium and 3) high rate of regular IV infusion. One subject completed a low and high insulin infusion study. One subject completed a medium and high insulin infusion study and one subject only underwent a medium insulin infusion study. All subjects received the same 4 doses of glucagon.

Participant Flow:   Overall Study
    All Study Participants  
STARTED     11  
COMPLETED     8  
NOT COMPLETED     3  
Withdrawal by Subject                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
All Study Participants Regular insulin given at each of three study visits with a different infusion rate at each visit, either low, medium or high insulin infusion with glucagon administration.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  11  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     0  
Gender  
[units: participants]
 
Female     5  
Male     6  



  Outcome Measures

1.  Primary:   Mean Difference in Area Under the Curve for Endogenous Glucose Production Between High and Low Insulin Infusion Rates   [ Time Frame: 60 minutes after each glucagon administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kenneth Ward
Organization: Legacy Health System
phone: 971-570-2632
e-mail: kenward503@msn.com


No publications provided


Responsible Party: W. Kenneth Ward, Legacy Health System
ClinicalTrials.gov Identifier: NCT01483651     History of Changes
Other Study ID Numbers: kw02
Study First Received: November 29, 2011
Results First Received: September 8, 2014
Last Updated: September 17, 2014
Health Authority: United States: Institutional Review Board