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| ID | Type | Description | Link |
|---|---|---|---|
| HD41890 |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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,
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| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia defined as <=70 mg/dL. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in epinephrine and glucagon levels. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William V Tamborlane, M.D. | Department of Pediatrics, Yale University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Pediatric Endocrinology and Diabetes, Stanford University | Stanford | California | 94305-5208 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16227041 | Background | Tsalikian E, Mauras N, Beck RW, Tamborlane WV, Janz KF, Chase HP, Wysocki T, Weinzimer SA, Buckingham BA, Kollman C, Xing D, Ruedy KJ; Diabetes Research In Children Network Direcnet Study Group. Impact of exercise on overnight glycemic control in children with type 1 diabetes mellitus. J Pediatr. 2005 Oct;147(4):528-34. doi: 10.1016/j.jpeds.2005.04.065. | |
| 16241867 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009043 | Motor Activity |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Barbara Davis Center for Childhood Diabetes, University of Colorado |
| Denver |
| Colorado |
| 80262 |
| United States |
| Department of Pediatrics, Yale University School of Medicine | New Haven | Connecticut | 06519 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| Department of Pediatrics, University of Iowa Carver College of Medicine | Iowa City | Iowa | 52242 | United States |
| Weinzimer SA, Beck RW, Chase HP, Fox LA, Buckingham BA, Tamborlane WV, Kollman C, Coffey J, Xing D, Ruedy KJ; Diabetes Research in Children Network Study Group. Accuracy of newer-generation home blood glucose meters in a Diabetes Research in Children Network (DirecNet) inpatient exercise study. Diabetes Technol Ther. 2005 Oct;7(5):675-80; discussion 681-3. doi: 10.1089/dia.2005.7.675. |
| 17659061 | Result | Diabetes Research in Children Network (DirecNet) Study Group. Impaired overnight counterregulatory hormone responses to spontaneous hypoglycemia in children with type 1 diabetes. Pediatr Diabetes. 2007 Aug;8(4):199-205. doi: 10.1111/j.1399-5448.2007.00248.x. |
| 16800753 | Result | Diabetes Research In Children Network (Direcnet) Study Group; Buckingham BA, Kollman C, Beck R, Kalajian A, Fiallo-Scharer R, Tansey MJ, Fox LA, Wilson DM, Weinzimer SA, Ruedy KJ, Tamborlane WV. Evaluation of factors affecting CGMS calibration. Diabetes Technol Ther. 2006 Jun;8(3):318-25. doi: 10.1089/dia.2006.8.318. |
| 16373890 | Result | Tansey MJ, Tsalikian E, Beck RW, Mauras N, Buckingham BA, Weinzimer SA, Janz KF, Kollman C, Xing D, Ruedy KJ, Steffes MW, Borland TM, Singh RJ, Tamborlane WV; Diabetes Research in Children Network (DirecNet) Study Group. The effects of aerobic exercise on glucose and counterregulatory hormone concentrations in children with type 1 diabetes. Diabetes Care. 2006 Jan;29(1):20-5. doi: 10.2337/diacare.29.1.20. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |