Milk as Treatment for Hypoglycemia

This study has been withdrawn prior to enrollment.
(Not funded)
Sponsor:
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00643110
First received: March 20, 2008
Last updated: July 13, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Drug: D50 glucose

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Milk as Treatment for Hypoglycemia

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Completion of 6 subjects. [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 0
Study Start Date: April 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: D50 glucose
    D50 glucose would be administered, if necessary.
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).

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 1 Diabetes
  • Able to be consented
  • Able to wear continuous glucose monitor
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00643110

Locations
United States, Nebraska
Creighton Diabetes Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
  More Information

No publications provided

Responsible Party: Marc S. Rendell, M.D., Creighton University
ClinicalTrials.gov Identifier: NCT00643110     History of Changes
Other Study ID Numbers: Rendell 01, Dairy Council - Rendell 01
Study First Received: March 20, 2008
Last Updated: July 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
Hypoglycemia

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014