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Carnitine Levels and Carnitine Supplementation in Type I Diabetes

This study has been completed.
Sponsor:
Collaborators:
Sigma Tau Pharmaceuticals, Inc.
Minimed Pharmaceuticals
Pharmacia/Upjohn Career Development Award
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00351234
First received: July 11, 2006
Last updated: February 24, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type I
Hypoglycemia
Drug: Carnitine (drug)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Correlation Between Carnitine Deficiency and Hypoglycemic Events in Type I Diabetes; Effects of Carnitine Supplementation on Hypoglycemic Events in Type I Diabetes

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • To see if there is a correlation between carnitine levels and number of hypoglycemic events. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • To see if carnitine values in a control population are significantly different than our study group. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: October 2004
Study Completion Date: April 2007
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   7 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  1. Children (male or female), between the ages of 7 and 21,
  2. who have had a diagnosis of Type 1 diabetes mellitus for at least two years and
  3. are currently on insulin replacement therapy.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351234

Locations
United States, Missouri
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Sigma Tau Pharmaceuticals, Inc.
Minimed Pharmaceuticals
Pharmacia/Upjohn Career Development Award
Investigators
Principal Investigator: Larry K Midyett, MD The Children's Mercy Hospital
  More Information

Publications:

Responsible Party: L. Kurt Midyett, MD, Assistant Professor, Children's Mercy Hospital
ClinicalTrials.gov Identifier: NCT00351234     History of Changes
Other Study ID Numbers: 000003020
Study First Received: July 11, 2006
Last Updated: February 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Diabetes Mellitus Type I,
Hypoglycemia,
Carnitine

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Carnitine
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 25, 2014