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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00109434 |
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.
Condition |
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Diabetes Mellitus, Type I |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | The Effect of Exercise on the Development of Hypoglycemia in Children With Type 1 Diabetes; A Study Being Conducted by the Diabetes Research in Children Network |
Estimated Enrollment: | 50 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | November 2004 |
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 that after exercise, the blood sugar may drop later in the day or during the night. However, it is not known how often this happens.
Also, not enough is known about how exercise affects blood sugar or the awareness of low blood sugar.
Some studies in adults have shown that exercise may affect the body's natural response to low blood sugar and exercise in the future.
For this study, each subject will have two in-patient hospital stays 1 to 4 weeks apart, each lasting about 24 hours: one with no exercise and one with a 75-minute exercise session in the late afternoon. (The order of the exercise and sedentary days will be determined at random.)
Prior to each hospital admission, each subject will keep a detailed diary of insulin use and hypoglycemia for one week.
On each of the two admissions, the insulin regimens and diet will be as similar as possible.
On each of the 2 admissions, the following will occur:
On the exercise day only,
Ages Eligible for Study: | 10 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Division of Pediatric Endocrinology and Diabetes, Stanford University | |
Stanford, California, United States, 94305-5208 | |
United States, Colorado | |
Barbara Davis Center for Childhood Diabetes, University of Colorado | |
Denver, Colorado, United States, 80262 | |
United States, Connecticut | |
Department of Pediatrics, Yale University School of Medicine | |
New Haven, Connecticut, United States, 06519 | |
United States, Florida | |
Nemours Children's Clinic | |
Jacksonville, Florida, United States, 32207 | |
United States, Iowa | |
Department of Pediatrics, University of Iowa Carver College of Medicine | |
Iowa City, Iowa, United States, 52242 |
Study Chair: | William V Tamborlane, M.D. | Department of Pediatrics, Yale University School of Medicine |
Study ID Numbers: | DirecNet 005, HD41890 |
Study First Received: | April 27, 2005 |
Last Updated: | January 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00109434 History of Changes |
Health Authority: | United States: Federal Government |
exercise hypoglycemia Diabetes Mellitus, Type I glucose monitoring |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Hypoglycemia Metabolic Disorder |
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia |