Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-29 @ 2:56 PM
Study NCT ID:
NCT00351234
Status:
COMPLETED
Last Update Posted:
2012-02-28
First Post:
2006-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carnitine Levels and Carnitine Supplementation in Type I Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002331', 'term': 'Carnitine'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}], 'ancestors': [{'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-24', 'studyFirstSubmitDate': '2006-07-11', 'studyFirstSubmitQcDate': '2006-07-11', 'lastUpdatePostDateStruct': {'date': '2012-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To see if there is a correlation between carnitine levels and number of hypoglycemic events.', 'timeFrame': 'one year'}, {'measure': 'To see if carnitine values in a control population are significantly different than our study group.', 'timeFrame': 'one year'}, {'measure': '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.', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus Type I,', 'Hypoglycemia,', 'Carnitine'], 'conditions': ['Diabetes Mellitus, Type I', 'Hypoglycemia']}, 'referencesModule': {'references': [{'pmid': '3524622', 'type': 'BACKGROUND', 'citation': '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': '642827', 'type': 'BACKGROUND', '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. doi: 10.1016/0026-0495(78)90022-7.'}, {'pmid': '6810706', 'type': 'BACKGROUND', 'citation': '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': '7957388', 'type': 'BACKGROUND', 'citation': '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': '6353846', 'type': 'BACKGROUND', 'citation': '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': '2816861', 'type': 'BACKGROUND', '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. doi: 10.1001/archpedi.1989.02150230095030."}, {'pmid': '8576570', 'type': 'BACKGROUND', 'citation': 'Pons R, De Vivo DC. Primary and secondary carnitine deficiency syndromes. J Child Neurol. 1995 Nov;10 Suppl 2:S8-24.'}, {'pmid': '3318304', 'type': 'BACKGROUND', 'citation': 'Stanley CA. New genetic defects in mitochondrial fatty acid oxidation and carnitine deficiency. Adv Pediatr. 1987;34:59-88.'}, {'pmid': '11927706', 'type': 'BACKGROUND', '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. doi: 10.1542/peds.109.4.622."}, {'pmid': '81361', 'type': 'BACKGROUND', '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. doi: 10.1016/s0140-6736(78)92587-4.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '7 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1. Children (male or female), between the ages of 7 and 21,\n2. who have had a diagnosis of Type 1 diabetes mellitus for at least two years and\n3. are currently on insulin replacement therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes Mellitus, Type I for greater than 2 years between the ages of 7 and 21\n* currently on insulin replacement therapy\n\nExclusion Criteria:\n\n* Patients with newly diagnosed Type I diabetes\n* Patients already taking L-carnitine\n* Patients who come to clinic without glucose monitors\n* Patients with known seizure disorders not including hypoglycemic seizures\n* Patients on metformin\n* Patients with compromised renal function.'}, 'identificationModule': {'nctId': 'NCT00351234', 'briefTitle': 'Carnitine Levels and Carnitine Supplementation in Type I Diabetes', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Correlation Between Carnitine Deficiency and Hypoglycemic Events in Type I Diabetes; Effects of Carnitine Supplementation on Hypoglycemic Events in Type I Diabetes', 'orgStudyIdInfo': {'id': '000003020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Carnitine (drug)', 'type': 'DRUG', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "The Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Larry K Midyett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital Kansas City"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'collaborators': [{'name': 'Leadiant Biosciences, Inc.', 'class': 'INDUSTRY'}, {'name': 'Minimed Pharmaceuticals', 'class': 'INDUSTRY'}, {'name': 'Pharmacia/Upjohn Career Development Award', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'L. Kurt Midyett, MD, Assistant Professor', 'oldOrganization': "Children's Mercy Hospital"}}}}