Heart rate variability training to improve glucose metabolism in prediabetes

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

This study is testing if breathing exercises that help regulate heart rate can improve blood sugar levels in people with prediabetes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Johannes Gutenberg University Mainz (Academic / other)
• Locations: 2 sites (Mainz, Mainz and 1 other locations)
• Trial ID: NCT06739993 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of heart rate variability biofeedback training combined with resonance frequency breathing on glucose metabolism in individuals diagnosed with prediabetes. The intervention aims to enhance autonomic nervous system function, which is believed to play a crucial role in insulin sensitivity and secretion. Participants will undergo a screening process to confirm their prediabetes status and will be trained in specific breathing techniques to potentially improve their metabolic health. The study seeks to provide a novel therapeutic approach for managing prediabetes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 with a diagnosis of prediabetes based on specific glucose level criteria.

Not a fit: Patients with diabetes or significant chronic diseases, as well as those with certain medical conditions affecting heart rate, will not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could help improve glucose metabolism and reduce the risk of developing type 2 diabetes in individuals with prediabetes.

How similar studies have performed: While the specific combination of techniques used in this study may be novel, previous studies have shown promising results in improving metabolic health through autonomic nervous system modulation.

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)

Where this trial is running

Mainz, Mainz and 1 other locations

• University Medical Center Mainz - Medical Psychology and Medical Sociology — Mainz, Mainz, Germany (Recruiting)
• University Medical Center of the Johannes-Gutenberg University, Department of Medical Psychology and Medical Sociology — Mainz, Rhineland-Palatinate, Germany (Not_yet_recruiting)

Study contacts

• Study coordinator: Benedict Herhaus, Ph.D.

Conditions Prediabetes; prediabetes; glucose metabolism; heart rate variability-biofeedback training; resonance frequency breathing; oral glucose tolerance test