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临床试验/NCT06139913
NCT06139913已完成不适用

Effect of Fat Burning Zone of Aerobic Exercise on Fitness Score and Blood Glucose Level in Adolescents Girls With Diabetes Mellitus

MTI University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Fitness score:

研究概览

简要总结

In adolescent diabetic girls, a correct life style, including diet and physical activity, is part of a correct intervention protocol. Thus, the aim of this study was to evaluate the effects of aerobic training intervention, based on heart rate at glycemic level , on clinical and physiological parameters in adolescent girls with type 1 diabetes forty type1 DM girls will randomly assigned to an intervention (study group ) or control group. The study group will perform a supervised aerobic exercise training based on heart rate whereas control group maintained their usual lifestyle. Anthropometric fitness score measures, blood analysis will assess at baseline and after intervention.

详细描述

fourty adolescents girls were diagnosed by physician as having type 1 diabetes mellitus and recruited from outpatient internal of El-Hussien hospital in Egypt . girls ages were between 13 and 18yr old; . The following inclusion criteria was applied to all participants in the study : all girls had type 1DM for more than 3 years, Their dose of insulin intake over 0.4 U/Kg/day, Body mass index (BMI) between 25 and 30 kg/m2 . Moderate-intensity aerobic exercise was defined according to the classification standard of the ACSM, which refers to exercise where the HRR of subjects is 64-76%; the moderate-intensity target heart rate area was set in advance and controlled by heart rate monitor during the intervention, and the menarche was began from 3 to 5 years. The patients had no history of severe and frequent hypoglycemia in the last 6 months (< 60 mg/dl, more than twice a week).

All participants attended a clinic for clinical assessments before and after treatment plane.

  1. Body Mass Index (BMI)
  2. Fitness score
  3. Target Heart Rate
  4. Fasting blood samples, post prandial and HbA1c: were taken for the following measurements: glucose.
  5. Estradiol blood test

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • All girls had type 1DM for more than 3 years,
  • Their didn't of insulin intake over 0.4 U/Kg/day, Body mass index (BMI) between 25 and 30 kg/m2

排除标准

  • Diabetes as a secondary condition
  • Any known cardiac defects and Macrovascular or microvascular chronical complications.
  • Insulin therapy and regulate dietary intake Were followed through diabetes physician.

结局指标

主要结局

Fitness score:

时间窗: 3 month

2- Fitness score: were assessed by multifrequency bioelectrical impedance analysis (MF-BIA; InBody 3.0, Biospace, Seoul, Korea)

Estradiol blood test

时间窗: 3 month

Estradiol blood test of the participants was done by a laboratory assistant to evaluate the estrogen level of the participants' pre- and post-exercise intervention. The serum concentrations of estradiol (E2) were analyses were performed on day 3 after onset of menstruation

Fasting blood samples, post prandial and HbA1c:

时间窗: 3 month

Fasting blood samples, post prandial and HbA1c: were taken for the following measurements: glucose.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rana Nabil Hussein Mohamed

Lecturer of pediatric physical therapy in MTIU

MTI University

研究点 (1)

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