Carnitine Levels and Carnitine Supplementation in Type I Diabetes

NCT00351234 | Completed

• 1 other identifier: 000003020
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type I; Hypoglycemia

Keywords

Diabetes Mellitus Type I,; Hypoglycemia,; Carnitine

Outcome Measures

Primary Outcomes (3)

• To see if there is a correlation between carnitine levels and number of hypoglycemic events.

  one year

• To see if carnitine values in a control population are significantly different than our study group.

  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.

  one year

Interventions

Carnitine (drug) 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.

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Diabetes Mellitus, Type I for greater than 2 years between the ages of 7 and 21
• currently on insulin replacement therapy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• Leadiant Biosciences, Inc.: collaborator
• Minimed Pharmaceuticals: collaborator
• Pharmacia/Upjohn Career Development Award: collaborator

Study Sites (1)

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (10)

• Rebouche CJ, Paulson DJ. Carnitine metabolism and function in humans. Annu Rev Nutr. 1986;6:41-66. doi: 10.1146/annurev.nu.06.070186.000353.

  PMID: 3524622 BACKGROUND

• 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. doi: 10.1016/0026-0495(78)90022-7.

  PMID: 642827 BACKGROUND

• Hoppel CL, Genuth SM. Urinary excretion of acetylcarnitine during human diabetic and fasting ketosis. Am J Physiol. 1982 Aug;243(2):E168-72. doi: 10.1152/ajpendo.1982.243.2.E168.

  PMID: 6810706 BACKGROUND

• 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. doi: 10.1007/BF02138779. No abstract available.

  PMID: 7957388 BACKGROUND

• 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. doi: 10.1111/j.1651-2227.1983.tb09762.x.

  PMID: 6353846 BACKGROUND

• 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. doi: 10.1001/archpedi.1989.02150230095030.

  PMID: 2816861 BACKGROUND

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

  PMID: 8576570 BACKGROUND

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

  PMID: 3318304 BACKGROUND

• 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. doi: 10.1542/peds.109.4.622.

  PMID: 11927706 BACKGROUND

• 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. doi: 10.1016/s0140-6736(78)92587-4.

  PMID: 81361 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

Carnitine; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Larry K Midyett, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2006
• First Posted: July 12, 2006
• Study Start: October 1, 2004
• Study Completion: April 1, 2007
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

US (1)