Study to Determine the Relationship Between Exercise and Hypoglycemia in Children With Type 1 Diabetes

Completed

Conditions studied: Diabetes Mellitus, Type I

In brief

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 that can predict if low blood sugar is going to develop. Blood samples will also be drawn to measure two hormones-glucagon and epinephrine (adrenaline)-to see how they are affected by exercise. Glucagon helps to raise the blood sugar when it is low. Epinephrine causes symptoms that make the person aware that the blood sugar is low. From the blood sample, other substances in the blood may also be measured to see how they are affected by exercise. A second purpose of the study is to find out whether exercise affects the accuracy of a continuous glucose sensor (CGMS made by Medtronic Minimed). The study will also look at the accuracy of different home glucose meters.

Key facts

Study ID

NCT00109434

Run by

Jaeb Center for Health Research

People needed

50

Starts

2004-06-01

Expected to finish

2004-11-01

Last updated by the study team

2016-09-05

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Division of Pediatric Endocrinology and Diabetes, Stanford University — Stanford, California, United States
• Barbara Davis Center for Childhood Diabetes, University of Colorado — Denver, Colorado, United States
• Department of Pediatrics, Yale University School of Medicine — New Haven, Connecticut, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• Department of Pediatrics, University of Iowa Carver College of Medicine — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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