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

RecruitingNAAges 18 Years - 65 YearsAllJohannes Gutenberg University Mainz
NCT06739993 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Approximately 20% of adults have prediabetes in Germany. Prediabetes is defined as a condition with glucose levels outside the normal range but not yet meeting the criteria for type 2 diabetes. The pathogenesis of prediabetes, as well as of type 2 diabetes, involves whole-body insulin resistance associated with inadequate insulin secretion. These two central processes of glucose regulation are modulated by the brain. The brain communicates via the autonomic nervous system (ANS) with metabolically important organs in the periphery to modulate insulin sensitivity and insulin secretion. These processes are impaired in individuals with prediabetes and diabetes. An ANS sympathovagal imbalance has also been observed in individuals with prediabetes. There are no specific therapeutic approaches to improve ANS sympathovagal imbalance. It is assumed that resonant frequency breathing (RFB) maximize

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📋 Eligibility rules (as published)
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)
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What it tests

  • Resonance frequency breathing with heart rate variability biofeedback training
  • Anti-Stress program
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Where

2 sites
University Medical Center Mainz - Medical Psychology and Medical Sociology
Mainz, Germany
University Medical Center of the Johannes-Gutenberg University, Department of Medical Psychology and Medical Sociology
Mainz, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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