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临床试验/NCT00351234
NCT00351234已完成不适用

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

Children's Mercy Hospital Kansas City1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2004年10月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
To see if there is a correlation between carnitine levels and number of hypoglycemic events.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
7 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: one year

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

时间窗: 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.

时间窗: one year

次要结局

未报告次要终点

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other

研究点 (1)

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