Carnitine Levels and Carnitine Supplementation in Type I Diabetes

February 24, 2012 updated by: Children's Mercy Hospital Kansas City

Correlation Between Carnitine Deficiency and Hypoglycemic Events in Type I Diabetes; Effects of Carnitine Supplementation on Hypoglycemic Events in Type I Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Carnitine (drug)

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Missouri
  - Kansas City, Missouri, United States, 64108
    - The Children's Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children (male or female), between the ages of 7 and 21,
who have had a diagnosis of Type 1 diabetes mellitus for at least two years and
are currently on insulin replacement therapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Collaborators

Leadiant Biosciences, Inc.

Minimed Pharmaceuticals

Pharmacia/Upjohn Career Development Award

Investigators

Principal Investigator: Larry K Midyett, MD, Children's Mercy Hospital Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

July 11, 2006

First Submitted That Met QC Criteria