Carnitine Levels and Carnitine Supplementation in Type I Diabetes
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|ClinicalTrials.gov Identifier: NCT00351234|
Recruitment Status : Completed
First Posted : July 12, 2006
Last Update Posted : February 28, 2012
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type I Hypoglycemia||Drug: Carnitine (drug)|
Hypoglycemia is a clinical marker of carnitine deficiency. Thus carnitine may compound the risk of hypoglycemia for children on insulin therapy. Currently, one of the limitations in the management of diabetes is hypoglycemia. The problem of hypoglycemia is of even greater significance in the pediatric population because children have smaller glycogen stores.
In this study, we will determine if there is a group of children with increased frequency of hypoglycemia and carnitine deficiency. If there is a correlation from the initial 200 children, we will compare two groups of type I diabetic children between the ages of 7 to 21 years. We will take 20 children with the highest carnitine levels (found in a previous study) and 20 children with the lowest carnitine levels and perform continuous glucose monitoring for a 72-hour period. Those who have at least one episode of hypoglycemia will be asked to undergo repeat testing, after a 2-week period of oral carnitine supplementation. Supplementation will start at 50 mg/kg body weight for the first week and then increase to 100 mg/kg body weight the second week. Laboratory studies obtained at baseline include Hemoglobin A1c, carnitine panel, and lipid panel. These will be repeated prior to the second continuous glucose monitoring. Insulin doses will not be changed between glucose monitoring sessions. A comparison will be made between individuals with hypoglycemia, to see if the number of hypoglycemic events has decreased.
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Correlation Between Carnitine Deficiency and Hypoglycemic Events in Type I Diabetes; Effects of Carnitine Supplementation on Hypoglycemic Events in Type I Diabetes|
|Study Start Date :||October 2004|
|Actual Study Completion Date :||April 2007|
- Drug: Carnitine (drug)
Oral L-carnitine will be obtained from Sigma Tau Pharmaceuticals. Supplementation will be initiated at 50mg/kg body weight and increased to 100mg/kg body weight after one week.
- To see if there is a correlation between carnitine levels and number of hypoglycemic events. [ Time Frame: one year ]
- To see if carnitine values in a control population are significantly different than our study group. [ Time Frame: one year ]
- To see if the number of hypoglycemic events decreases with treatment of carnitine on type I diabetic patients. The measurements will be taken after the second 72-hour continuous glucose monitoring. [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351234
|United States, Missouri|
|The Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Larry K Midyett, MD||Children's Mercy Hospital Kansas City|