Delayed Gastric EmptyingNCT07375680
HbA1c Levels and Gastric Emptying Assessed by Gastric Ultrasound
An observational study of Delayed Gastric Emptying and Diabetes Mellitus, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Delayed gastric emptying increases the risk of pulmonary aspiration during general anesthesia. Diabetes mellitus and poor long-term glycemic control have been associated with impaired gastric motility. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Delayed Gastric Emptying, Diabetes Mellitus, Pulmonary Aspiration
- How many people
- 134 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2026to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18 to 70 years scheduled for elective surgery under general anesthesia at a tertiary care hospital.
Who may be able to join
- Adults aged 18 to 70 years. ASA physical status I-III. Scheduled for elective surgery under general anesthesia. Ability to provide written informed consent.
Who cannot join
- Scheduled for emergency surgery. Refusal or inability to provide informed consent. Pregnancy. Age <18 years or >70 years. History of gastric surgery. Neuromuscular disease. Current use of opioid or anticholinergic medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kutahya Health Science University Training and Research Hospital
Kütahya, Kütahya
merve yaman, MD, Assitant Professor, +905363794742, merve.yaman@ksbu.edu.tr
emine gök, MD, +905050270167, emine.gok@ksbu.gov.tr
About this study
Official title: Evaluation of the Effect of Hemoglobin A1c Levels on Gastric Emptying Assessed by Gastric Ultrasound
Delayed gastric emptying increases the risk of pulmonary aspiration during general anesthesia. Diabetes mellitus and poor long-term glycemic control have been associated with impaired gastric motility. Hemoglobin A1c (HbA1c) is a marker of long-term glycemic control; however, its relationship with gastric emptying in surgical patients is not fully understood.
This prospective observational study aims to evaluate the association between HbA1c levels and gastric emptying using preoperative bedside gastric ultrasonography. Adult patients scheduled for elective surgery under general anesthesia will undergo gastric ultrasound examination after standard fasting. Gastric antral cross-sectional area and estimated gastric volume will be assessed and compared according to HbA1c levels.
The findings of this study may help improve preoperative risk stratification for aspiration and support individualized anesthetic management in patients with impaired glycemic control.
Read the detailed description
This prospective observational study is designed to evaluate the relationship between hemoglobin A1c (HbA1c) levels and gastric emptying in adult surgical patients using bedside gastric ultrasonography.
Adult patients aged 18 to 70 years, scheduled for elective surgery under general anesthesia, will be enrolled. After standard preoperative fasting according to current guidelines, all participants will undergo a preoperative gastric ultrasound examination performed by a trained anesthesiologist. The gastric antrum will be assessed in standardized positions, and the antral cross-sectional area will be measured. Estimated gastric volume will be calculated using validated ultrasound-based formulas.
HbA1c levels will be obtained from preoperative laboratory records, and patients will be analyzed according to their HbA1c values. Gastric ultrasound findings, including antral cross-sectional area and estimated gastric volume, will be compared across different HbA1c levels.
Demographic data, anthropometric measurements including body mass index and waist circumference, fasting duration, and relevant clinical characteristics will also be recorded. The primary objective is to assess the association between HbA1c levels and gastric emptying parameters. Secondary analyses will explore potential factors associated with delayed gastric emptying.
The results of this study may contribute to improved preoperative risk assessment for pulmonary aspiration and support individualized anesthetic management in patients with impaired glycemic control.
- Keywords
- Hemoglobin A1c, Gastric Ultrasonography, General Anesthesia, Preoperative Assessment
- Medical subject headings
- Gastroparesis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Adult patients scheduled for elective surgery under general anesthesia who undergo preoperative bedside gastric ultrasonography as part of an observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying assessed by gastric ultrasound
Gastric emptying will be assessed preoperatively using bedside gastric ultrasonography by measuring gastric antrum cross-sectional area and estimating gastric volume with validated ultrasound-based methods.
Measured: The preoperative period,immediately before induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start15 Feb 2026
- Primary completion15 Aug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Gastric EmptyingStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Yaman, Kutahya Health Sciences University
- Investigators
- merve yaman, MD, Assistant Professor, Principal investigator, Kutahya Health Science Universityemine gök, MD, Study director, Kutahya Health Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375680
- Sponsor's protocol ID
- KHSU-HbA1c-GastricUS
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Hemoglobin A1c Levels on Gastric Emptying Assessed by Gastric Ultrasound
- ClinicalTrials.gov ID
- NCT07375680
- Acronym / sponsor ID
- KHSU-HbA1c-GastricUS
- Keywords
- Hemoglobin A1c, Gastric Ultrasonography, General Anesthesia, Preoperative Assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 29 Jan 2026 (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.
Delayed gastric emptying increases the risk of pulmonary aspiration during general anesthesia. Diabetes mellitus and poor long-term glycemic control have been associated with impaired gastric motility. Hemoglobin A1c (HbA1c) is a marker of long-term glycemic control; however, its relationship with gastric emptying in surgical patients is not fully understood.
This prospective observational study aims to evaluate the association between HbA1c levels and gastric emptying using preoperative bedside gastric ultrasonography. Adult patients scheduled for elective surgery under general anesthesia will undergo gastric ultrasound examination after standard fasting. Gastric antral cross-sectional area and estimated gastric volume will be assessed and compared according to HbA1c levels.
The findings of this study may help improve preoperative risk stratification for aspiration and support individualized anesthetic management in patients with impaired glycemic control.
Detailed description
This prospective observational study is designed to evaluate the relationship between hemoglobin A1c (HbA1c) levels and gastric emptying in adult surgical patients using bedside gastric ultrasonography.
Adult patients aged 18 to 70 years, scheduled for elective surgery under general anesthesia, will be enrolled. After standard preoperative fasting according to current guidelines, all participants will undergo a preoperative gastric ultrasound examination performed by a trained anesthesiologist. The gastric antrum will be assessed in standardized positions, and the antral cross-sectional area will be measured. Estimated gastric volume will be calculated using validated ultrasound-based formulas.
HbA1c levels will be obtained from preoperative laboratory records, and patients will be analyzed according to their HbA1c values. Gastric ultrasound findings, including antral cross-sectional area and estimated gastric volume, will be compared across different HbA1c levels.
Demographic data, anthropometric measurements including body mass index and waist circumference, fasting duration, and relevant clinical characteristics will also be recorded. The primary objective is to assess the association between HbA1c levels and gastric emptying parameters. Secondary analyses will explore potential factors associated with delayed gastric emptying.
The results of this study may contribute to improved preoperative risk assessment for pulmonary aspiration and support individualized anesthetic management in patients with impaired glycemic control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | –Adult patients scheduled for elective surgery under general anesthesia who undergo preoperative bedside gastric ultrasonography as part of an observational study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 to 70 years scheduled for elective surgery under general anesthesia at a tertiary care hospital.
Key inclusion criteria (1 listed)
- Adults aged 18 to 70 years. ASA physical status I-III. Scheduled for elective surgery under general anesthesia. Ability to provide written informed consent.
Key exclusion criteria (1 listed)
- Scheduled for emergency surgery. Refusal or inability to provide informed consent. Pregnancy. Age <18 years or >70 years. History of gastric surgery. Neuromuscular disease. Current use of opioid or anticholinergic medications.
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
Gastric emptying assessed by gastric ultrasound
Time frame: The preoperative period,immediately before induction of anesthesia
Gastric emptying will be assessed preoperatively using bedside gastric ultrasonography by measuring gastric antrum cross-sectional area and estimating gastric volume with validated ultrasound-based methods.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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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.
merve yaman, MD, Assistant Professor principal investigator
Kutahya Health Science University
emine gök, MD study director
Kutahya Health Science University
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 Delayed Gastric Emptying and Diabetes Mellitus, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Apr 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact merve yaman, MD, Assistant Professor (+905363794742, merve.yaman@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric emptying assessed by gastric ultrasound (time frame: The preoperative period,immediately before induction of anesthesia). 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 8 Apr 2026.