Hypoglycemia Fear Affect Autonomic Function, Physical Activity, and Exercise Capacity in Type I Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention (observational study).
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes Mellitus. Basic parameters: 10 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Does Fear of Hypoglycemia Affect Autonomic Function, Physical Activity, and Exercise Capacity in Children and Adolescents With Type I Diabetes?
Overview
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.
Detailed description
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.
Interventions
- Other No intervention (observational study)
No interventions; patient-reported, functional performance-based and HRV analysis.
Primary outcome measures
- The University of Virginia Child/Teen Low Blood Sugar Survey (C-LBSS) [Time frame: Baseline (Day 1)]
Secondary outcome measures (4)
- Autonomic Function [Time frame: Baseline and immediately post-ISWT (Day 1)]
- Physical Activity Questionnaire for Older Children (PAQ-C) [Time frame: Baseline (Day 1)]
- Physical Activity Questionnaire for Adolescents (PAQ-A) [Time frame: Baseline]
- Incremental shuttle walking test (ISWT) [Time frame: Baseline (day 1)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Turkey (Türkiye) · 1 center
- Ordu University Training and Research Hospital — Ordu
Publications
- 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
Identifiers
NCT: NCT07527676 · 27/03/2026