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Trial record 3 of 1011 for:    Area Under Curve AND insulin

Physiologic Response to Glucagon at Varying Insulin Levels

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ClinicalTrials.gov Identifier: NCT01483651
Recruitment Status : Completed
First Posted : December 1, 2011
Results First Posted : September 22, 2014
Last Update Posted : March 29, 2016
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Oregon Health and Science University
Information provided by (Responsible Party):
W. Kenneth Ward, Legacy Health System

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Basic Science
Condition Type 1 Diabetes Mellitus
Interventions Drug: Glucagon
Drug: Insulin
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low, Medium and High Insulin Infusion Rate Low, High and Medium Insulin Infusion Rate Medium, Low and High Insulin Infusion Rate Medium, High and Low Insulin Infusion High, Low and Medium Insulin Infusion High, Medium and Low Insulin Infusion
Hide Arm/Group Description

All study subjects in this arm were randomized as follows:

First study is regular insulin infused at lowest level with glucagon administration.

Second study is regular insulin infused at medium level with glucagon adminstration.

Third study is regular insulin infused at highest level with glucagon administration.

All study subjects in this arm were randomized as follows:

First study is regular insulin infused at lowest level with glucagon administration.

Second study is regular insulin infused at highest level with glucagon adminstration.

Third study is regular insulin infused at medium level with glucagon administration.

All study subjects in this arm were randomized as follows:

First study is regular insulin infused at medium level with glucagon administration.

Second study is regular insulin infused at lowest level with glucagon adminstration.

Third study is regular insulin infused at highest level with glucagon administration.

All study subjects in this arm were randomized as follows:

First study is regular insulin infused at medium level with glucagon administration.

Second study is regular insulin infused at highest level with glucagon adminstration.

Third study is regular insulin infused at lowest level with glucagon administration.

All study subjects in this arm were randomized as follows:

First study is regular insulin infused at highest level with glucagon administration.

Second study is regular insulin infused at lowest level with glucagon adminstration.

Third study is regular insulin infused at medium level with glucagon administration.

All study subjects in this arm were randomized as follows:

First study is regular insulin infused at highest level with glucagon administration.

Second study is regular insulin infused at medium level with glucagon adminstration.

Third study is regular insulin infused at lowest level with glucagon administration.

Period Title: Overall Study
Started 1 3 2 1 2 2
Completed 1 2 1 1 2 1
Not Completed 0 1 1 0 0 1
Reason Not Completed
Withdrawal by Subject             0             1             1             0             0             1
Arm/Group Title All Study Participants
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
5
  45.5%
Male
6
  54.5%
1.Primary Outcome
Title Area Under the Curve for Glucose Above Baseline
Hide Description The change in the rate of glucose appearance will be assessed by measuring the stable glucose isotope (dideuterated glucose, D2) using a gas chromatography-mass spectrometry assay. The units of the area under the curve are defined as milligrams per kilogram of glucose, since the dependent variable is a rate of glucose production [mg/kg/min] measured over time [min]. The time variable therefore cancels out. Additionally, this area under the curve is being normalized per microgram of glucagon delivered.
Time Frame 60 minutes after each glucagon administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Insulin Infusion Rate Medium Insulin Infusion Rate High Insulin Infusion Rate
Hide Arm/Group Description:
Regular insulin infused at lowest level of glucagon administration.
Regular insulin infused at medium level with glucagon administration.
Regular insulin infused at highest level with glucagon administration.
Overall Number of Participants Analyzed 10 9 10
Mean (Standard Deviation)
Unit of Measure: mg/kg glucose per mcg glucagon
0.623  (0.3) 0.59  (0.4) 0.03  (0.16)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Insulin Infusion Medium Insulin Infusion High Insulin Infusion
Hide Arm/Group Description Regular insulin infused at lowest level with glucagon administration. Regular insulin infused at medium level with glucagon administration. regular insulin infused at highest level with glucagon administration.
All-Cause Mortality
Low Insulin Infusion Medium Insulin Infusion High Insulin Infusion
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Low Insulin Infusion Medium Insulin Infusion High Insulin Infusion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/9 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low Insulin Infusion Medium Insulin Infusion High Insulin Infusion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/10 (70.00%)      8/9 (88.89%)      5/10 (50.00%)    
Blood and lymphatic system disorders       
Hematoma   1/10 (10.00%)  1 0/9 (0.00%)  0 0/10 (0.00%)  0
ketosis   0/10 (0.00%)  0 1/9 (11.11%)  1 0/10 (0.00%)  0
Gastrointestinal disorders       
Diarrhea *  3/10 (30.00%)  4 2/9 (22.22%)  3 3/10 (30.00%)  3
vomiting *  1/10 (10.00%)  1 1/9 (11.11%)  1 1/10 (10.00%)  1
nausea *  5/10 (50.00%)  5 2/9 (22.22%)  2 4/10 (40.00%)  4
Metabolism and nutrition disorders       
hyperglycemia   1/10 (10.00%)  1 2/9 (22.22%)  2 0/10 (0.00%)  0
hypoglycemia   1/10 (10.00%)  1 2/9 (22.22%)  2 0/10 (0.00%)  0
Musculoskeletal and connective tissue disorders       
weakness *  1/10 (10.00%)  1 1/9 (11.11%)  1 1/10 (10.00%)  1
Nervous system disorders       
headache *  2/10 (20.00%)  2 3/9 (33.33%)  3 2/10 (20.00%)  2
Renal and urinary disorders       
excessive thirst *  1/10 (10.00%)  1 0/9 (0.00%)  0 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders       
extravasation   0/10 (0.00%)  0 0/9 (0.00%)  0 1/10 (10.00%)  1
dermititis *  0/10 (0.00%)  0 0/9 (0.00%)  0 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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
Responsible Party: W. Kenneth Ward, Legacy Health System
ClinicalTrials.gov Identifier: NCT01483651     History of Changes
Other Study ID Numbers: kw02
First Submitted: November 29, 2011
First Posted: December 1, 2011
Results First Submitted: September 8, 2014
Results First Posted: September 22, 2014
Last Update Posted: March 29, 2016