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临床试验/NCT07527676
NCT07527676尚未招募不适用

Does Fear of Hypoglycemia Affect Autonomic Function, Physical Activity, and Exercise Capacity in Children and Adolescents With Type I Diabetes?

Ordu University1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2026年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
67
试验地点
1
主要终点
The University of Virginia Child/Teen Low Blood Sugar Survey (C-LBSS)

研究概览

简要总结

This cross-sectional study aims to investigate whether fear of hypoglycemia affects autonomic function, physical activity levels, and exercise capacity in children and adolescents with T1DM.

The main question it aims to answer is:

Does Fear of Hypoglycemia Affect Autonomic Function, Physical Activity, and Exercise Capacity in Children and Adolescents with Type I Diabetes? Participants will answer questionnaires about fear of Hypoglycemia and physical activity. Heart rate (HR), heart rate variability (HRV), blood pressure (BP), and peripheral oxygen saturation (SpO₂) will evaluate for autonomic function.

详细描述

Fear of hypoglycemia (FoH) is a specific fear caused by the risk and/or occurrence of hypoglycemia, and is associated with the frequency of severe hypoglycemic episodes, particularly during the past 3 months. FoH is a major barrier to physical activity and exercise in children and adolescents in T1DM. . Hypoglycaemic stress provides an ideal model with which to examine the interactions and consequences of physiological stress on the autonomic nervous system (ANS). Acute hypoglycaemia has been shown to increase inflammatory markers and impair cardiac-vagal baroreflex sensitivity, and exacerbate autonomic and cardiovascular dysregulation in adults with T1DM. Recurrent hypoglycemia can weaken autonomic responses and reduce awareness of hypoglycemia, which can increase FoH in individuals, leading to behavioral changes and impaired glycemic control. Therefore this study aims to investigate whether fear of hypoglycemia affects autonomic function, physical activity levels, and exercise capacity in children and adolescents with T1DM. Participants will answer questionnaires about fear of Hypoglycemia and physical activity. Heart rate (HR), heart rate variability (HRV), blood pressure (BP), and peripheral oxygen saturation (SpO₂) will evaluate for autonomic function. Incremental shuttle walking test will use to assess exercise capacity of participants.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • being aged 10-18 years,
  • having been diagnosed with T1DM at least one year ago,
  • having an HbA1c of ≤7% in the last three months,
  • being literate in Turkish,
  • voluntarily participating in the study.

排除标准

  • visual, auditory or cognitive problems that would prevent participation, orthopaedic or neurological problems (e.g. walking or running difficulties) that would prevent participation,
  • BMI <18.5 kg/m², any complications related to T1DM,
  • being in the insulin/sensor dose adjustment/adjustment phase or having a history of diabetic ketoacidosis in the last month.

研究组 & 干预措施

Type 1 Diabetes Participants

Children and adolecants with Type 1DM participating in autonomic function, exercise capacity, and physical activity assessments. No intervention is applied beyond standard care.

干预措施: No intervention (observational study) (Other)

结局指标

主要结局

The University of Virginia Child/Teen Low Blood Sugar Survey (C-LBSS)

时间窗: Baseline (Day 1)

C-LBSS was developed to assess FoH in children and adolescents. The Turkish version of C-LBSS with Cronbach's alpha of 0.843 and a test-retest correlation of 0.997 will used to assess FoH in this study. It consists of 25 items and includes two sub-dimensions measuring children's/adolescents' levels of hypoglycemia-related behaviors (items 1-10) and anxiety (items 11-25). Items are rated on a 5-point Likert scale (0 = "never" to 4 = "almost always"), and the total score on the scale ranges from 0 to 100, with an increase in the score indicating increased FoH.

次要结局

  • Autonomic Function(Baseline and immediately post-ISWT (Day 1))
  • Physical Activity Questionnaire for Older Children (PAQ-C)(Baseline (Day 1))
  • Physical Activity Questionnaire for Adolescents (PAQ-A)(Baseline)
  • Incremental shuttle walking test (ISWT)(Baseline (day 1))

研究者

发起方
Ordu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Semiha Yenişehir

Principal Investigator

Ordu University

研究点 (1)

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