Study to Determine the Relationship Between Exercise and Hypoglycemia in Children With Type 1 Diabetes
|First Received Date ICMJE||April 27, 2005|
|Last Updated Date||September 2, 2016|
|Start Date ICMJE||June 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Hypoglycemia defined as <=70 mg/dL.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00109434 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Changes in epinephrine and glucagon levels.|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Study to Determine the Relationship Between Exercise and Hypoglycemia in Children With Type 1 Diabetes|
|Official Title ICMJE||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|
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.
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,
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Diabetes Mellitus, Type I|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||November 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||10 Years to 17 Years (Child)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00109434|
|Other Study ID Numbers ICMJE||DirecNet 005
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Jaeb Center for Health Research|
|Study Sponsor ICMJE||Jaeb Center for Health Research|
|Collaborators ICMJE||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|PRS Account||Jaeb Center for Health Research|
|Verification Date||September 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP