Milk as Treatment for Hypoglycemia

Type 1 Diabetes Clinical Trial

Official title:

Milk as Treatment for Hypoglycemia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00643110
• Other study ID #: Rendell 01
• Secondary ID: Dairy Council -
• Status: Withdrawn
• Phase: N/A
• First received: March 20, 2008
• Last updated: March 24, 2015
• Start date: April 2008
• Est. completion date: January 2009

Study information

• Verified date: March 2015
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Type 1 Diabetes

• Able to be consented

• Able to wear continuous glucose monitor

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoglycemia
• Type 1 Diabetes

Intervention

Drug:
• D50 glucose
D50 glucose would be administered, if necessary.

Locations

Country	Name	City	State
United States	Creighton Diabetes Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of 6 subjects.		One year	Yes