Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109434
Status:
COMPLETED
Last Update Posted:
2016-09-05
First Post:
2005-04-27
Brief Title:
Study to Determine the Relationship Between Exercise and Hypoglycemia in Children With Type 1 Diabetes
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 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 bodys 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
A CGMS sensor will be inserted and calibrated
An intravenous catheter for the collection of blood samples will be inserted
Blood sugar measurements will be made with an Ultra BD Logic and Freestyle meter every half hour beginning at 1000 pm through 600 am
Blood samples for glucagon epinephrine and glucose will be collected hourly from 1000 pm to 600 am
On the exercise day only
In the morning the subject will run on the treadmill for about 5 minutes to determine the settings needed to achieve a heart rate of 140
Exercise will begin at approximately 400PM and will consist of 15 minutes on a treadmill at a heart rate of approximately 140 followed by a 5-minute rest period This cycle will be repeated 3 more times for a total of four 15-minute exercise periods with 5-minute rest periods in between 75 minutes total A heart rate monitor will be worn throughout the time of exercise to ascertain the effort put forth
BG blood glucose measurements will be made using the Ultra BD Logic and Freestyle meters 1 prior to starting the exercise 2 during each of the 3 rest periods 3 immediately following the exercise session and 4 at 15 minute intervals for one hour following the completion of the exercise Blood samples will be collected for the central lab at the times of sampling for glucagon and epinephrine
Some studies in adults have shown that exercise may affect the bodys 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
A CGMS sensor will be inserted and calibrated
An intravenous catheter for the collection of blood samples will be inserted
Blood sugar measurements will be made with an Ultra BD Logic and Freestyle meter every half hour beginning at 1000 pm through 600 am
Blood samples for glucagon epinephrine and glucose will be collected hourly from 1000 pm to 600 am
On the exercise day only
In the morning the subject will run on the treadmill for about 5 minutes to determine the settings needed to achieve a heart rate of 140
Exercise will begin at approximately 400PM and will consist of 15 minutes on a treadmill at a heart rate of approximately 140 followed by a 5-minute rest period This cycle will be repeated 3 more times for a total of four 15-minute exercise periods with 5-minute rest periods in between 75 minutes total A heart rate monitor will be worn throughout the time of exercise to ascertain the effort put forth
BG blood glucose measurements will be made using the Ultra BD Logic and Freestyle meters 1 prior to starting the exercise 2 during each of the 3 rest periods 3 immediately following the exercise session and 4 at 15 minute intervals for one hour following the completion of the exercise Blood samples will be collected for the central lab at the times of sampling for glucagon and epinephrine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HD41890 | None | None | None |