Carnitine Levels and Carnitine Supplementation in Type I Diabetes

Completed

• Conditions: Diabetes Mellitus, Type I; Hypoglycemia

• Registration Number: NCT00351234
• Lead Sponsor: Children's Mercy Hospital Kansas City

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 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 Timeline

• Study Start: 2004-10
• Study First Submitted: 2006-07-11
• Study First Submitted QC: 2006-07-11
• Study First Posted: 2006-07-12
• Study Completion: 2007-04
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-24
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Diabetes Mellitus, Type I for greater than 2 years between the ages of 7 and 21
• currently on insulin replacement therapy

Exclusion Criteria

• Patients with newly diagnosed Type I diabetes
• Patients already taking L-carnitine
• Patients who come to clinic without glucose monitors
• Patients with known seizure disorders not including hypoglycemic seizures
• Patients on metformin
• Patients with compromised renal function.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To see if there is a correlation between carnitine levels and number of hypoglycemic events.	one year
To see if carnitine values in a control population are significantly different than our study group.	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.	one year

Trial Locations

Locations (1)

The Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States