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Carnitine Levels and Carnitine Supplementation in Type I Diabetes
This study is currently recruiting participants.
Verified by Children's Mercy Hospital Kansas City, July 2006
Sponsors and Collaborators: Children's Mercy Hospital Kansas City
Sigma Tau Pharmaceuticals, Inc.
Minimed Pharmaceuticals
Pharmacia/Upjohn Career Development Award
Information provided by: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00351234
  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)

MedlinePlus related topics: Diabetes Diabetes Type 1 Hypoglycemia
Drug Information available for: Carnitine
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: Correlation Between Carnitine Deficiency and Hypoglycemic Events in Type I Diabetes; Effects of Carnitine Supplementation on Hypoglycemic Events in Type I Diabetes

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

Estimated Enrollment: 200
Study Start Date: October 2004
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351234

Contacts
Contact: Larry K Midyett, MD 816-234-1660 ext 8238 kmidyett@cmh.edu
Contact: Chetanbabu M Patel, MD 847-234-1660 ext 6589 chpatel@cmh.edu

Locations
United States, Missouri
The Children's Mercy Hospital Recruiting
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:
Rebouche CJ, Paulson DJ. Carnitine metabolism and function in humans. Annu Rev Nutr. 1986;6:41-66. Review.
Frohlich J, Seccombe DW, Hahn P, Dodek P, Hynie I. Effect of fasting on free and esterified carnitine levels in human serum and urine: correlation with serum levels of free fatty acids and beta-hydroxybutyrate. Metabolism. 1978 May;27(5):555-61.
Hoppel CL, Genuth SM. Urinary excretion of acetylcarnitine during human diabetic and fasting ketosis. Am J Physiol. 1982 Aug;243(2):E168-72.
Bohles H, Evangeliou A, Bervoets K, Eckert I, Sewell A. Carnitine esters in metabolic disease. Eur J Pediatr. 1994;153(7 Suppl 1):S57-61. Review. No abstract available.
Soltesz G, Melegh B, Sandor A. The relationship between carnitine and ketone body levels in diabetic children. Acta Paediatr Scand. 1983 Jul;72(4):511-5.
Winter SC, Simon M, Zorn EM, Szabo-Aczel S, Vance WH, O'Hara T, Higashi L. Relative carnitine insufficiency in children with type I diabetes mellitus. Am J Dis Child. 1989 Nov;143(11):1337-9.
Pons R, De Vivo DC. Primary and secondary carnitine deficiency syndromes. J Child Neurol. 1995 Nov;10 Suppl 2:S8-24. Review.
Stanley CA. New genetic defects in mitochondrial fatty acid oxidation and carnitine deficiency. Adv Pediatr. 1987;34:59-88. Review.
O'Donnell J, Finer NN, Rich W, Barshop BA, Barrington KJ. Role of L-carnitine in apnea of prematurity: a randomized, controlled trial. Pediatrics. 2002 Apr;109(4):622-6.
Maebashi M, Kawamura N, Sato M, Imamura A, Yoshinaga K. Lipid-lowering effect of carnitine in patients with type-IV hyperlipoproteinaemia. Lancet. 1978 Oct 14;2(8094):805-7.

Study ID Numbers: 000003020
Study First Received: July 11, 2006
Last Updated: July 11, 2006
ClinicalTrials.gov Identifier: NCT00351234  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia
Carnitine

Additional relevant MeSH terms:
Vitamin B Complex
Immune System Diseases
Growth Substances
Vitamins
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009