Effects of Autonomic Nervous System Modulation by Heart Rate Variability Biofeedback Training Wit… (NCT06739993) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Autonomic Nervous System Modulation by Heart Rate Variability Biofeedback Training With Resonant Frequency Breathing on Glucose Metabolism in Individuals With Prediabetes
Germany60 participantsStarted 2025-05-14
Plain-language summary
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) maximizes heart rate variability (HRV) through rhythmization of breathing, heartbeat, and blood pressure. Through this state of coherence, the activity of the parasympathetic nervous system is upregulated, and the activity of the sympathetic nervous system is suppressed, leading to an increase in modulation of ANS activity. Several studies have demonstrated that heart rate variability-biofeedback (HRV-BF) interventions improve HRV, reduce stress and anxiety, and alleviate symptoms in patients with various medical conditions. To the best of current knowledge, no study has investigated the effect of HRV-BF-RFB on glucose metabolism. Therefore, the proposed randomized controlled non-blinded trial aims to gain evidence about the effect of HRV-BF-RFB compared to an anti-stress program on glucose metabolism in individuals with prediabetes. Glucose metabolism is characterized using the 75 g oral glucose tolerance test. There are two potential mechanisms by which HRV-BF-RFB may improve glucose metabolism in individuals with prediabetes: (a) a 0°-phase relationship between heart oscillations and breathing, maximizing the amplitude of respiratory sinus arrhythmia (RSA), and (b) activation of the cholinergic anti-inflammatory pathway. The investigators hypothesized that in individuals with prediabetes, the HRV-BF-RFB intervention will improve glucose metabolism and glucose variability.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses something called heart rate variability biofeedback with resonant frequency breathing to try to affect blood sugar — can you explain how training my nervous system this way might actually influence my glucose metabolism, and does that make sense given my specific prediabetes situation?
2Since this trial is listed as Phase NA, meaning it's not a traditional drug trial with standard safety phases, what do we actually know so far about whether this biofeedback breathing approach is safe and effective for people with prediabetes like me?
3The trial is focused on autonomic nervous system modulation — could you help me understand whether my own stress levels or nervous system function might be contributing to my prediabetes, and if so, whether this kind of intervention addresses what's driving my condition?
4Given that this is a recruiting study still gathering data on glucose metabolism outcomes, would it make more sense for me to first try established lifestyle interventions like diet changes and exercise — which already have strong evidence for prediabetes — before considering a research trial like this one?
5What would actually be required of me day-to-day if I enrolled in this trial, and how time-intensive is learning and practicing heart rate variability biofeedback with resonant frequency breathing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.