NCT07527676

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 67 (estimated)
• Sponsor: Ordu University · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	No intervention (observational study)	No interventions; patient-reported, functional performance-based and HRV analysis.

Timeline

• Start date: 2026-05-02
• Primary completion: 2026-06-30
• Completion: 2026-07-30
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: Turkey (Türkiye)