HypoglycemiaNCT07132476
The Construction and Validation of a Risk Prediction Model for Perioperative Hypoglycemia in Digestive Endoscopy
An observational study of Hypoglycemia, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
Digestive endoscopic surgery, including diagnosis and treatment interventions, has become an indispensable means of managing various gastrointestinal diseases in modern gastroenterology practice. Perioperative hypoglycemia is a common but not fully recognized complication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- No adjuvant therapy
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Jun 2024
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients undergoing endoscopic treatment and surgery
Who may be able to join
- Age ≥ 18 years;
- Endoscopic surgical methods include endoscopic retrograde cholangiopancreatography (ERCP), endoscopic mucosal resection/stripping (endoscopic mucosal resection, EMR/endoscopic submucosal dissection, ESD), high-frequency electroresection or cold resection of polyps, endoscopic hemostasis, and endoscopic ultrasound-guided puncture, etc.; ③ Patients who have given informed consent and voluntarily participate in the survey.
Who cannot join
- ① Those who cannot cooperate with the questionnaire survey;
- ② Those who cannot cooperate with postoperative diet and fluid management or blood glucose monitoring.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 312000
About this study
Digestive endoscopic surgery, including diagnosis and treatment interventions, has become an indispensable means of managing various gastrointestinal diseases in modern gastroenterology practice. Perioperative hypoglycemia is a common but not fully recognized complication. The reported incidence rate of different study populations and types of surgery ranges from 6.75% to 17.50%. The clinical consequences of endoscopic hypoglycemia are profound. Recurrent attacks are associated with an increased risk of transient ischemic attacks and other cardiovascular and cerebrovascular events. From the perspective of the healthcare system, hypoglycemia may reduce patients' compliance with the intake of intestinal cleaning agents, leading to inadequate intestinal preparation, affecting the effectiveness of diagnosis and treatment, prolonging endoscopic surgery time, increasing hospitalization days and costs. This study aims to develop and validate a comprehensive nomogram that integrates three key dimensions: traditional metabolic risk factors (diabetes status, fasting time), program variables (infusion rate, somatostatin use), and new psychosocial factors (anxiety, sleep quality). By using machine learning enhanced logistic regression to prospectively collect data from 610 patients from multiple centers, the resulting column chart model provides clinical doctors with a practical tool for personalized risk stratification and targeted intervention measures, such as reducing anxiety protocols or optimizing fluid management for high-risk patients. The purpose of this study is to identify the influencing factors of hypoglycemia during the perioperative period of digestive endoscopy, help identify and screen high-risk populations, provide theoretical basis for the development of intervention measures, reduce the occurrence of hypoglycemia during the perioperative period of endoscopy, improve patient satisfaction, and reduce hospitalization time and costs.
- Conditions
- Hypoglycemia
- Being tested
- No adjuvant therapy
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No adjuvant therapyOther
Observe and record hypoglycemia
| Study group | Role | What they receive |
|---|---|---|
| hypoglycemia group | Not described Receives: Other: No adjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypoglycemia
Measured: perioperative period of the endoscopic
hypoglycemia
Measured: the perioperative period of the endoscopic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Jan 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132476
- Sponsor's protocol ID
- hexiaoyingningbo1
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
He X, Yang Y, Han Y, Zhang Z. Development and validation of a novel nomogram incorporating psychosocial factors for predicting hypoglycemia during perioperative period of digestive endoscopy (DREAM-Hypo Model). BMC Gastroenterol. 2025 Oct 16;25(1):740. doi: 10.1186/s12876-025-04315-x.
PubMed 41102649
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Construction and Validation of a Risk Prediction Model for Perioperative Hypoglycemia in Digestive Endoscopy
- ClinicalTrials.gov ID
- NCT07132476
- Acronym / sponsor ID
- hexiaoyingningbo1
- Conditions
- Hypoglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 20 Aug 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.
Digestive endoscopic surgery, including diagnosis and treatment interventions, has become an indispensable means of managing various gastrointestinal diseases in modern gastroenterology practice. Perioperative hypoglycemia is a common but not fully recognized complication. The reported incidence rate of different study populations and types of surgery ranges from 6.75% to 17.50%. The clinical consequences of endoscopic hypoglycemia are profound. Recurrent attacks are associated with an increased risk of transient ischemic attacks and other cardiovascular and cerebrovascular events. From the perspective of the healthcare system, hypoglycemia may reduce patients' compliance with the intake of intestinal cleaning agents, leading to inadequate intestinal preparation, affecting the effectiveness of diagnosis and treatment, prolonging endoscopic surgery time, increasing hospitalization days and costs. This study aims to develop and validate a comprehensive nomogram that integrates three key dimensions: traditional metabolic risk factors (diabetes status, fasting time), program variables (infusion rate, somatostatin use), and new psychosocial factors (anxiety, sleep quality). By using machine learning enhanced logistic regression to prospectively collect data from 610 patients from multiple centers, the resulting column chart model provides clinical doctors with a practical tool for personalized risk stratification and targeted intervention measures, such as reducing anxiety protocols or optimizing fluid management for high-risk patients. The purpose of this study is to identify the influencing factors of hypoglycemia during the perioperative period of digestive endoscopy, help identify and screen high-risk populations, provide theoretical basis for the development of intervention measures, reduce the occurrence of hypoglycemia during the perioperative period of endoscopy, improve patient satisfaction, and reduce hospitalization time and costs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypoglycemia group | – | Other: No adjuvant therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing endoscopic treatment and surgery
Key inclusion criteria (2 listed)
- Age ≥ 18 years;
Key exclusion criteria (2 listed)
- ① Those who cannot cooperate with the questionnaire survey;
- ② Those who cannot cooperate with postoperative diet and fluid management or blood glucose monitoring.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No adjuvant therapyObserve and record hypoglycemia | Other | hypoglycemia group |
Primary outcome
hypoglycemia
Time frame: perioperative period of the endoscopic
hypoglycemia
Time frame: the perioperative period of the endoscopic
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 20 Aug 2025.
- Derived from this study: PubMed 41102649He X, Yang Y, Han Y, Zhang Z. Development and validation of a novel nomogram incorporating psychosocial factors for predicting hypoglycemia during perioperative period of digestive endoscopy (DREAM-Hypo Model). BMC Gastroenterol. 2025 Oct 16;25(1):740. doi: 10.1186/s12876-025-04315-x.
- Individual participant dataSharing planned: Yes
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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 Hypoglycemia, run by Ningbo No. 1 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 2 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 20 Aug 2025. 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?
hypoglycemia (time frame: perioperative period of the endoscopic). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07132476, which also lists 1 linked publication.
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 20 Aug 2025.