Gastric VolumeNCT07483593
Baseline Gastric Volume in Diabetic vs Non-Diabetic Patients
An observational study of Gastric Volume and Preoperative Fasting, run by Kocaeli University at 2 sites in Turkey (Türkiye).
Trial summary
During the preoperative preparation process, the fasting period for anesthesia is planned according to guidelines. According to standard guidelines, a fasting period of at least 2 hours is recommended for clear liquids, at least 6 hours for light meals, and at least 8 hours for a full meal. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Volume, Preoperative Fasting, Diabetes Mellitus
- What is being tested?
- Gastric Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Apr 2026to 15 Nov 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of diabetic and non-diabetic adult patients aged 18-75 years, ASA physical status I-III, with BMI ≤40 kg/m2, scheduled for elective surgery.
Who may be able to join
- Ages 18-75
- ASA I-III
- BMI ≤ 40 kg/m2
Who cannot join
- Patients with a history of gastrointestinal surgery,
- Pregnant women,
- Patients with documented abnormalities in the upper gastrointestinal tract, such as achalasia
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Kocaeli University
Kocaeli
Sevim CESUR, MD, +902623038248
Sevim Cesur
Kocaeli
About this study
Official title: Baseline Gastric Volume Measurement in Diabetic and Non-Diabetic Patients: A Non-Inferiority Study
During the preoperative preparation process, the fasting period for anesthesia is planned according to guidelines. According to standard guidelines, a fasting period of at least 2 hours is recommended for clear liquids, at least 6 hours for light meals, and at least 8 hours for a full meal. However, it has been reported that these guidelines are valid for healthy patients. It is thought that the planned fasting periods may vary in diabetic patients due to delayed gastric emptying. This study aims to calculate gastric volume under ultrasonography guidance and compare it with fasting time.
Read the detailed description
Aspiration of gastric contents is the most important risk factor for pulmonary aspiration. Pulmonary aspiration is a serious perioperative complication and can lead to lung damage. The main factor in the development of this complication is the presence of a "full stomach" during induction. This can result from non-compliance with fasting protocols or delayed gastric emptying. Although the incidence of gastric content aspiration is low in patients scheduled for elective surgery, the risk factor is considered increased in diabetic patients due to delayed gastric emptying caused by autonomic dysfunction. Prior to surgery, a bedside ultrasound will be performed on the morning of the operation by an experienced anesthesiologist who is unaware of the patient's diabetes mellitus status, using a standard gastric screening protocol. Evaluation of the gastric antrum will be performed by two experienced anesthesiologists using a portable ultrasound device with a convex low-frequency (2-5 MHz) probe, first in the supine position and then in the right lateral decubitus position.
- Conditions
- Gastric Volume, Preoperative Fasting, Diabetes Mellitus
- Being tested
- Gastric Ultrasound
- Keywords
- Gastric Ultrasound, Gastric Volume, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric UltrasoundProcedure or surgery
Also called Preoperative Gastric Ultrasound
Preoperative gastric ultrasonography will be performed to assess gastric antral cross-sectional area and estimate residual gastric volume in patients scheduled for elective surgery. The examination will be performed in the supine and right lateral decubitus positions using a low-frequency convex probe by experienced anesthesiologists.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Patients with diabetes mellitus scheduled for elective surgery undergoing preoperative gastric ultrasound assessment to measure baseline gastric volume. Receives: Procedure: Gastric Ultrasound | |
| Non-diabetic patients | Patients without diabetes mellitus scheduled for elective surgery undergoing preoperative gastric ultrasound assessment to measure baseline gastric volume. Receives: Procedure: Gastric Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative residual gastric volume
Assessment of whether standard preoperative fasting guidelines provide an empty stomach in diabetic patients by comparing estimated residual gastric volume measured with gastric ultrasonography between diabetic and non-diabetic patients scheduled for elective surgery
Measured: Preoperative period
Secondary outcomes (2)
Association between diabetes severity and gastric volume
Evaluation of the relationship between diabetes severity and preoperative residual gastric volume.
Measured: Preoperative assessment
Baseline gastric volume comparison
Comparison of baseline gastric volume between diabetic and non-diabetic patients undergoing elective surgery.
Measured: Preoperative assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start20 Apr 2026 (estimated)
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric VolumeStudies 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
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim Cesur, Kocaeli University
- Investigators
- Sevim CESUR, MD, Study director, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483593
- Sponsor's protocol ID
- GOKAEK-2025/14/33
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 19 Mar 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Gastric Volume Measurement in Diabetic and Non-Diabetic Patients: A Non-Inferiority Study
- ClinicalTrials.gov ID
- NCT07483593
- Acronym / sponsor ID
- GOKAEK-2025/14/33
- Conditions
- Gastric Volume, Preoperative Fasting, Diabetes Mellitus
- Keywords
- Gastric Ultrasound, Gastric Volume, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 19 Mar 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.
During the preoperative preparation process, the fasting period for anesthesia is planned according to guidelines. According to standard guidelines, a fasting period of at least 2 hours is recommended for clear liquids, at least 6 hours for light meals, and at least 8 hours for a full meal. However, it has been reported that these guidelines are valid for healthy patients. It is thought that the planned fasting periods may vary in diabetic patients due to delayed gastric emptying. This study aims to calculate gastric volume under ultrasonography guidance and compare it with fasting time.
Detailed description
Aspiration of gastric contents is the most important risk factor for pulmonary aspiration. Pulmonary aspiration is a serious perioperative complication and can lead to lung damage. The main factor in the development of this complication is the presence of a "full stomach" during induction. This can result from non-compliance with fasting protocols or delayed gastric emptying. Although the incidence of gastric content aspiration is low in patients scheduled for elective surgery, the risk factor is considered increased in diabetic patients due to delayed gastric emptying caused by autonomic dysfunction. Prior to surgery, a bedside ultrasound will be performed on the morning of the operation by an experienced anesthesiologist who is unaware of the patient's diabetes mellitus status, using a standard gastric screening protocol. Evaluation of the gastric antrum will be performed by two experienced anesthesiologists using a portable ultrasound device with a convex low-frequency (2-5 MHz) probe, first in the supine position and then in the right lateral decubitus position.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | – | Procedure: Gastric UltrasoundPatients with diabetes mellitus scheduled for elective surgery undergoing preoperative gastric ultrasound assessment to measure baseline gastric volume. |
| Non-diabetic patients | – | Procedure: Gastric UltrasoundPatients without diabetes mellitus scheduled for elective surgery undergoing preoperative gastric ultrasound assessment to measure baseline gastric volume. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of diabetic and non-diabetic adult patients aged 18-75 years, ASA physical status I-III, with BMI ≤40 kg/m2, scheduled for elective surgery.
Key inclusion criteria (3 listed)
- Ages 18-75
- ASA I-III
- BMI ≤ 40 kg/m2
Key exclusion criteria (3 listed)
- Patients with a history of gastrointestinal surgery,
- Pregnant women,
- Patients with documented abnormalities in the upper gastrointestinal tract, such as achalasia
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 |
|---|---|---|
| Gastric UltrasoundAlso: Preoperative Gastric UltrasoundPreoperative gastric ultrasonography will be performed to assess gastric antral cross-sectional area and estimate residual gastric volume in patients scheduled for elective surgery. The examination will be performed in the supine and right lateral decubitus positions using a low-frequency convex probe by experienced anesthesiologists. | Procedure or surgery | Diabetic patients, Non-diabetic patients |
Primary outcome
Preoperative residual gastric volume
Time frame: Preoperative period
Assessment of whether standard preoperative fasting guidelines provide an empty stomach in diabetic patients by comparing estimated residual gastric volume measured with gastric ultrasonography between diabetic and non-diabetic patients scheduled for elective surgery
2 secondary outcomes
Association between diabetes severity and gastric volume
Time frame: Preoperative assessment
Baseline gastric volume comparison
Time frame: Preoperative assessment
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 19 Mar 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.
Sevim CESUR, MD study director
Kocaeli University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Volume and Preoperative Fasting, run by Kocaeli University at 2 sites 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 19 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 2 sites 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 Sevim CESUR, MD (+902623038248, svmcsr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative residual gastric volume (time frame: Preoperative period). 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 19 Mar 2026.