Milk as Treatment for Hypoglycemia
Primary Purpose
Type 1 Diabetes
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
D50 glucose
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Hypoglycemia
Eligibility Criteria
Inclusion Criteria:
- Type 1 Diabetes
- Able to be consented
- Able to wear continuous glucose monitor
Sites / Locations
- Creighton Diabetes Center
Outcomes
Primary Outcome Measures
Completion of 6 subjects.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00643110
Brief Title
Milk as Treatment for Hypoglycemia
Official Title
Milk as Treatment for Hypoglycemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Not funded
Study Start Date
April 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Creighton University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Test hypothesis that milk can raise blood sugars as well as orange juice or glucose tablets without raising blood sugars too much the way that orange juice or glucose tablets sometimes do.
Detailed Description
Subjects will wear a continuous glucose monitor prior to test to determine normal glucose levels. The morning of the test an IV will be inserted into the subject and insulin and saline drips will be started. Blood glucose levels will be checked every 10 minutes until the subject becomes hypoglycemic. IVs will be stopped at that time and subject will be given skim milk, orange juice or glucose tablets at that time. Blood will be drawn every 15 minutes until blood sugars stabilize. Blood draws will be analyzed to determine glucose, insulin, epinephrine, norepinephrine, glucagon, cortisol, growth hormone and GLP-1 levels. Procedure will be repeated two more times using other glucose methods (skim milk, orange juice or glucose tablets).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Hypoglycemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
D50 glucose
Intervention Description
D50 glucose would be administered, if necessary.
Primary Outcome Measure Information:
Title
Completion of 6 subjects.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Type 1 Diabetes
Able to be consented
Able to wear continuous glucose monitor
Facility Information:
Facility Name
Creighton Diabetes Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Milk as Treatment for Hypoglycemia
We'll reach out to this number within 24 hrs