Status:
COMPLETED
Study to Determine the Relationship Between Exercise and Hypoglycemia in Children With Type 1 Diabetes
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus, Type I
Eligibility:
All Genders
10-17 years
Brief Summary
The main purpose of this study is to find out how often low blood sugar (hypoglycemia) happens during the night after exercise in the late afternoon. The study also will see if there are any factors t...
Detailed Description
Many children and adults with type 1 diabetes have a drop in the blood sugar during exercise. When someone has low blood sugar, the body tries to return the blood sugar to normal. Some studies show th...
Eligibility Criteria
Inclusion
- Clinical diagnosis of type 1 diabetes for at least 18 months
- HbA1c \<10.0% as measured by the DCA2000.
- Age 10.0 to \<18.0 years
- Weight \>36.0 kg
- BMI (body mass index) \>5th and \<95th percentiles for age/gender
- Stable insulin regimen for at least 1 month and not anticipating a change prior to the subject's completion of the study
- Insulin regimen involves either use of an insulin pump or Lantus (with short-acting insulin)
- NPH or Lente, if part of the insulin regimen, is given only in the morning before breakfast
- Normal hematocrit (within normal limits of local laboratory)
- Normal thyroid function (measured within the previous year)
- Parent/guardian and subject understand the study protocol and agree to comply with it
- Informed Consent Form signed by the parent/guardian and Child Assent Form signed
Exclusion
- Insulin regimen includes Ultralente/Lente or NPH at times other than the morning before breakfast
- A recent injury to body or limb, Addison's disease, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
- Asthma which has been medically treated within the last year
- Current use of glucocorticoid medication (by any route of administration)
- Current use of a beta blocker medication
- Use of pseudoephedrine 48 hours prior to CRC admission (if used in the 48 hours prior to the scheduled second admission, the admission will be deferred)
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 2 weeks prior to CRC admission (if a severe episode occurs within 2 weeks prior to the scheduled second admission, the admission will be deferred)
- Active infection (if at the time of the planned second admission an infection is present, the admission will be deferred)
- Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport)
Key Trial Info
Start Date :
June 1 2004
Trial Type :
OBSERVATIONAL
End Date :
November 1 2004
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00109434
Start Date
June 1 2004
End Date
November 1 2004
Last Update
September 5 2016
Active Locations (5)
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1
Division of Pediatric Endocrinology and Diabetes, Stanford University
Stanford, California, United States, 94305-5208
2
Barbara Davis Center for Childhood Diabetes, University of Colorado
Denver, Colorado, United States, 80262
3
Department of Pediatrics, Yale University School of Medicine
New Haven, Connecticut, United States, 06519
4
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207