Effects of Autonomic Nervous System Modulation by Heart Rate Variability Biofeedback Training With Resonant Frequency Breathing on Glucose Metabolism in Individuals With Prediabetes

Launched by JOHANNES GUTENBERG UNIVERSITY MAINZ · Dec 13, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new training method called heart rate variability biofeedback with resonant frequency breathing to see if it can improve glucose metabolism in individuals with prediabetes. Prediabetes means your blood sugar levels are higher than normal but not high enough to be considered diabetes. The study aims to find out if this breathing technique can help regulate blood sugar levels by improving the balance of the autonomic nervous system, which controls various body functions, including how our body manages insulin and glucose.

To participate, you need to be between the ages of 18 and 65 and have prediabetes, which is determined through a specific blood test. Unfortunately, people with diabetes, certain serious medical conditions, or those on specific medications may not be eligible. If you join the study, you’ll learn about and practice this breathing technique, and researchers will monitor how it affects your glucose levels during a test that measures how your body responds to sugar. This trial could offer new insights into managing prediabetes effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Presence of prediabetes Fasting glucose: 100-125 mg/dl (5.6-6.9 mmol/L) and/or HbA1c in %: 5.7-6.4 (39-47 mmol/mol Hb) and/or 2-hour value of the 75 g OGTT: 140-199 mg/dl (7.8-11.0 mmol/L)
• • This is checked using a 75 g OGTT in a screening visit.
• • Age between 18 and 65 years
• • BMI between 20 and 40 kg/m²
• Exclusion Criteria:
• • Diabetes mellitus
• • Malignant diseases within the last 5 years before randomization
• • History of gastrointestinal surgery
• • Pancreatic diseases other than pancreatic lipomatosis
• • Acute diseases or infections
• • Regular intake of cardiac drugs that affect heart rate within the last 4 weeks before the first measurement (e.g. beta-receptor blockers, antiarrhythmics, etc.)
• • Intake of centrally acting drugs
• • Medical contraindications to a meaningful interpretation of the heart rate analysis (e.g. patients with pacemakers, atrial fibrillation or other arrhythmias)
• • Chronic diseases (particularly metabolic diseases, heart diseases, blood diseases)
• • Endocrinological disease other than substituted hypothyroidism
• • Mental illnesses
• • Intake of drugs that can affect blood sugar metabolism (e.g. steroids)