Heart rate variability training to improve glucose metabolism in prediabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: bherhaus@uni-mainz.de
• Phone: 004961313929140

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.