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Набор скоро начнётся NCT07527676

Hypoglycemia Fear Affect Autonomic Function, Physical Activity, and Exercise Capacity in Type I Diabetes

— Наблюдательное Type 1 Diabetes Mellitus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No intervention (observational study).
Кому может быть актуально
Состояния в реестре: Type 1 Diabetes Mellitus. Базовые параметры: 10 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое No intervention (observational study)
    No interventions; patient-reported, functional performance-based and HRV analysis.

Первичные конечные точки

  • The University of Virginia Child/Teen Low Blood Sugar Survey (C-LBSS) [Срок оценки: Baseline (Day 1)]
Вторичные конечные точки (4)
  • Autonomic Function [Срок оценки: Baseline and immediately post-ISWT (Day 1)]
  • Physical Activity Questionnaire for Older Children (PAQ-C) [Срок оценки: Baseline (Day 1)]
  • Physical Activity Questionnaire for Adolescents (PAQ-A) [Срок оценки: Baseline]
  • Incremental shuttle walking test (ISWT) [Срок оценки: Baseline (day 1)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Turkey (Türkiye) · 1 центр
  • Ordu University Training and Research Hospital — Ordu

Публикации

  • Limberg JK, Farni KE, Taylor JL, Dube S, Basu A, Basu R, Wehrwein EA, Joyner MJ. Autonomic control during acute hypoglycemia in type 1 diabetes mellitus. Clin Auton Res. 2014 Dec;24(6):275-83. doi: 10.1007/s10286-014-0253-y. Epub 2014 Sep 27. PMID 25260537
  • Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019. PMID 1494764
  • The University of Virginia Child/Teen Low Blood Sugar Survey: Turkish Validity and Reliability Study
  • Erdim L, Ergun A, Kuguoglu S. Reliability and validity of the Turkish version of the Physical Activity Questionnaire for Older Children (PAQ-C). Turk J Med Sci. 2019 Feb 11;49(1):162-169. doi: 10.3906/sag-1806-212. PMID 30764593

Идентификаторы

NCT: NCT07527676 · 27/03/2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗