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Breathing technique may tune the nervous system to improve blood sugar

NCT ID NCT06739993

Disease control Sponsor: Johannes Gutenberg University Mainz Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests whether a specific breathing exercise, called resonant frequency breathing with heart rate variability biofeedback, can improve how the body handles sugar in people with prediabetes. The training aims to calm the body's stress response by increasing heart rate variability, which may positively influence glucose metabolism. Sixty adults with prediabetes will be randomly assigned to either this breathing training or an anti-stress program, and their glucose metabolism will be measured using an oral glucose tolerance test.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Resonance frequency breathing with heart rate variability biofeedback training
What this could lead to
If effective, this drug-free breathing technique could offer a new way to help people with prediabetes improve blood sugar control and potentially lower their risk of developing type 2 diabetes.
What could go wrong
This is an early-stage trial with a modest number of participants, so results may not be conclusive or widely applicable. The training requires regular practice, and its effect on glucose metabolism is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

prediabetes syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prediabetes

How to take part

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  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University Medical Center Mainz - Medical Psychology and Medical Sociology

    RECRUITING

    Mainz, Mainz, 55128, Germany

  • University Medical Center of the Johannes-Gutenberg University, Department of Medical Psychology and Medical Sociology

    NOT_YET_RECRUITING

    Mainz, Rhineland-Palatinate, 55128, Germany

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