HyperglycemiaNCT07198308
Association Between Blood Glucose Indicators and Heart Rate Variability in Non-diabetic Critically Ill Patients
An observational study of Hyperglycemia, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Heart rate variability (HRV) is a simple way to check how well the body's automatic nervous system is working. It does this by looking at how the heart rate changes in the electrocardiogram. HRV can be divided into time domain and frequency domain. Time domain indicators assess the tone of the autonomic nerves. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hyperglycemia
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 13 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: Adult patients who were hospitalized in the Intensive Care Unit of Zhongshan Hospital Affiliated to Fudan University after the start of the study.
Who may be able to join
- Aged from 18 to 99 years old
- Informed consent has been signed
Who cannot join
- Under 18 years old
- Diagnosed with diabetes either prior to or during hospitalization
- Missing HRV values
- Missing blood glucose and random insulin values
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Association Between Blood Glucose Indicators and Heart Rate Variability in Non-diabetic Critically Ill Patients: a Single-center Prospective Study
Heart rate variability (HRV) is a simple way to check how well the body's automatic nervous system is working. It does this by looking at how the heart rate changes in the electrocardiogram. HRV can be divided into time domain and frequency domain. Time domain indicators assess the tone of the autonomic nerves. Frequency domain indicators reflect the regulation of the sympathetic and parasympathetic nerves. An imbalance of the body's nervous system can be reflected by HRV. Stress hyperglycemia (SIH) is when your blood glucose levels go up because of an acute disease. This is usually related to the body's stress response, but if your blood glucose levels go up too much, it can lead to complications. A high blood sugar level caused by stress is common in intensive care units. There is a strong link between this and the death rate and how long patients stay there. There are lots of nerve endings in the pancreas. Nerve fibres control the way islet α/β cells work to keep the right amount of glucose in the blood. We know that the pancreatic nerve is important for controlling blood glucose levels, but we don't fully understand how it does this.
- Conditions
- Hyperglycemia
- Medical subject headings
- Hyperglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between glucagon and HRV in non-diabetic critically ill patients
Measured: From enrollment to completion of indicator testing (within 24 hours)
Secondary outcomes (1)
The correlation between blood glucose and random insulin levels and HRV in non-diabetic critically ill patients
Measured: From enrollment to completion of indicator testing (within 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Oct 2025
- Primary completion31 Dec 2025
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198308
- Sponsor's protocol ID
- B2025-586
- Status last verified
- Mar 2026
- First submitted
- 22 Sep 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Blood Glucose Indicators and Heart Rate Variability in Non-diabetic Critically Ill Patients: a Single-center Prospective Study
- ClinicalTrials.gov ID
- NCT07198308
- Acronym / sponsor ID
- B2025-586
- Conditions
- Hyperglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart rate variability (HRV) is a simple way to check how well the body's automatic nervous system is working. It does this by looking at how the heart rate changes in the electrocardiogram. HRV can be divided into time domain and frequency domain. Time domain indicators assess the tone of the autonomic nerves. Frequency domain indicators reflect the regulation of the sympathetic and parasympathetic nerves. An imbalance of the body's nervous system can be reflected by HRV. Stress hyperglycemia (SIH) is when your blood glucose levels go up because of an acute disease. This is usually related to the body's stress response, but if your blood glucose levels go up too much, it can lead to complications. A high blood sugar level caused by stress is common in intensive care units. There is a strong link between this and the death rate and how long patients stay there. There are lots of nerve endings in the pancreas. Nerve fibres control the way islet α/β cells work to keep the right amount of glucose in the blood. We know that the pancreatic nerve is important for controlling blood glucose levels, but we don't fully understand how it does this.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients who were hospitalized in the Intensive Care Unit of Zhongshan Hospital Affiliated to Fudan University after the start of the study.
Key inclusion criteria (2 listed)
- Aged from 18 to 99 years old
- Informed consent has been signed
Key exclusion criteria (4 listed)
- Under 18 years old
- Diagnosed with diabetes either prior to or during hospitalization
- Missing HRV values
- Missing blood glucose and random insulin values
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between glucagon and HRV in non-diabetic critically ill patients
Time frame: From enrollment to completion of indicator testing (within 24 hours)
1 secondary outcome
The correlation between blood glucose and random insulin levels and HRV in non-diabetic critically ill patients
Time frame: From enrollment to completion of indicator testing (within 24 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycemia, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between glucagon and HRV in non-diabetic critically ill patients (time frame: From enrollment to completion of indicator testing (within 24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.