Carnitine Levels and Carnitine Supplementation in Type I Diabetes

Hypoglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00351234
• Other study ID #: 000003020
• Status: Completed
• Phase: N/A
• First received: July 11, 2006
• Last updated: February 24, 2012
• Start date: October 2004
• Est. completion date: April 2007

Study information

• Verified date: February 2012
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 21 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type I
• Hypoglycemia

Intervention

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.

Locations

Country	Name	City	State
United States	The Children's Mercy Hospital	Kansas City	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	Minimed Pharmaceuticals, Pharmacia/Upjohn Career Development Award, Sigma Tau Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (10)

Böhles 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. — View Citation

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. — View Citation

Hoppel CL, Genuth SM. Urinary excretion of acetylcarnitine during human diabetic and fasting ketosis. Am J Physiol. 1982 Aug;243(2):E168-72. — View Citation

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. — View Citation

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. — View Citation

Pons R, De Vivo DC. Primary and secondary carnitine deficiency syndromes. J Child Neurol. 1995 Nov;10 Suppl 2:S8-24. Review. — View Citation

Rebouche CJ, Paulson DJ. Carnitine metabolism and function in humans. Annu Rev Nutr. 1986;6:41-66. Review. — View Citation

Soltész G, Melegh B, Sándor A. The relationship between carnitine and ketone body levels in diabetic children. Acta Paediatr Scand. 1983 Jul;72(4):511-5. — View Citation

Stanley CA. New genetic defects in mitochondrial fatty acid oxidation and carnitine deficiency. Adv Pediatr. 1987;34:59-88. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To see if there is a correlation between carnitine levels and number of hypoglycemic events.		one year	Yes
Primary	To see if carnitine values in a control population are significantly different than our study group.		one year	No
Primary	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	Yes