Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351234
Status:
COMPLETED
Last Update Posted:
2012-02-28
First Post:
2006-07-11
Brief Title:
Carnitine Levels and Carnitine Supplementation in Type I Diabetes
Sponsor:
Childrens Mercy Hospital Kansas City
Organization:
Childrens Mercy Hospital Kansas City
Study Overview
Official Title:
Correlation Between Carnitine Deficiency and Hypoglycemic Events in Type I Diabetes Effects of Carnitine Supplementation on Hypoglycemic Events in Type I Diabetes
Status:
COMPLETED
Status Verified Date:
2012-02
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 purpose of this study is to determine whether type I diabetics with carnitine deficiency exhibit increased numbers of hypoglycemic low blood sugars events and if unrecognized hypoglycemia occurs during continuous 72-hour glucose monitoring If they are determined to have unrecognized hypoglycemia then oral carnitine supplementation will be given to those subjects and they will be reassessed for the number of hypoglycemic events in a 72-hour glucose monitoring
Detailed Description:
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 mgkg body weight for the first week and then increase to 100 mgkg 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
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 mgkg body weight for the first week and then increase to 100 mgkg 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 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