Carnitine Levels and Carnitine Supplementation in Type I Diabetes

Condition(s) targeted: Diabetes Mellitus, Type I; Hypoglycemia

Intervention: Carnitine (drug) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Children's Mercy Hospital Kansas City

Official(s) and/or principal investigator(s):
Larry K Midyett, MD, Principal Investigator, Affiliation: The Children's Mercy Hospital

Overall contact:
Larry K Midyett, MD, Phone: 816-234-1660, Ext: 8238, Email: kmidyett@cmh.edu

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.

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

Study design: Natural History, Longitudinal, Defined Population, Prospective Study

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.

Minimum age: 7 Years. Maximum age: 21 Years. Gender(s): Both.

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.

Larry K Midyett, MD, Phone: 816-234-1660, Ext: 8238, Email: kmidyett@cmh.edu

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

Related 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.

Starting date: October 2004
Last updated: July 11, 2006