Type 2 Diabetes Mellitus (DM)NCT07842757
Preoperative Gastric Volume and High-Risk Gastric Content in Patients With Type 2 Diabetes Mellitus
An observational study of Type 2 Diabetes Mellitus (DM) and Gastric Ultrasound, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study will evaluate adult patients with type 2 diabetes mellitus who are scheduled for elective surgery. Immediately before preoperative gastric ultrasonography, capillary fasting blood glucose will be measured. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (DM), Gastric Ultrasound
- What is being tested?
- Preoperative Gastric Ultrasonography and Capillary Fasting Blood Glucose Measurement
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 1 Apr 2027
- Phase
- Observational
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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with type 2 diabetes mellitus who are scheduled for elective surgery at University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital and who meet the study eligibility criteria.
Who may be able to join
- Age 18 years or older
- Diagnosis of type 2 diabetes mellitus
- American Society of Anesthesiologists (ASA) physical status II or III
- Scheduled for elective surgery
- Suitable for preoperative gastric ultrasonography
- Provision of written informed consent
Who cannot join
- Pregnancy
- Body mass index ≥40 kg/m²
- Emergency surgery
- History of gastric, esophageal, or upper gastrointestinal surgery
- Presence of a nasogastric tube
- Known gastroparesis or gastric outlet obstruction
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- Active vomiting
- Systemic opioid or prokinetic drug use within the previous 72 hours
- Anatomical or technical conditions preventing adequate gastric ultrasonographic assessment
- Impaired consciousness or inability to provide a reliable medical history
- Refusal to participate in the study
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
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Istanbul, 34147
Fatma Çiğdem Özakın, MD, +905464168250, f.cigdemulus@gmail.com
About this study
Official title: Clinical and Metabolic Determinants of High Residual Gastric Volume in Patients With Type 2 Diabetes Mellitus
This prospective observational study will evaluate adult patients with type 2 diabetes mellitus who are scheduled for elective surgery. Immediately before preoperative gastric ultrasonography, capillary fasting blood glucose will be measured.
Gastric contents will be assessed qualitatively in the supine and right lateral decubitus positions, and residual gastric volume will be estimated using the antral cross-sectional area measured in the right lateral decubitus position.
Read more
The primary objective is to evaluate the association between fasting capillary blood glucose and the presence of a high-risk stomach. A high-risk stomach will be defined as the presence of solid gastric contents, Perlas Grade 2 gastric contents, or an estimated gastric volume greater than 1.5 mL/kg.
Secondary objectives include determining the prevalence of a high-risk stomach and evaluating its associations with demographic characteristics, diabetes-related factors, comorbidities, fasting duration, medication use, gastroparesis-related symptoms, and routine laboratory parameters.
Read the detailed description
This is a single-center, prospective observational study involving adult patients with type 2 diabetes mellitus scheduled for elective surgery.
On the day of surgery, participants will be evaluated in the preoperative preparation area before anesthesia induction and before administration of sedative premedication. Demographic data, diabetes duration and treatment, diabetes-related complications, comorbidities, smoking status, symptoms potentially associated with gastroparesis, fasting duration, and routinely available laboratory parameters will be recorded.
Capillary fasting blood glucose will be measured immediately before gastric ultrasonography and will constitute the primary independent variable.
Gastric ultrasonography will be performed by a trained and experienced investigator using a low-frequency convex transducer. The gastric antrum will be assessed first in the supine position and then in the right lateral decubitus position. Gastric contents will be classified as empty, clear fluid, or solid content. Clear fluid findings will additionally be classified according to the Perlas grading system.
For quantitative assessment, anteroposterior and craniocaudal diameters of the gastric antrum will be measured and the antral cross-sectional area will be calculated. Estimated gastric volume will be calculated from the right lateral decubitus antral cross-sectional area and expressed both in mL and mL/kg.
A high-risk stomach will be defined by at least one of the following findings: solid gastric contents, clear fluid visible in both the supine and right lateral decubitus positions (Perlas Grade 2), or estimated gastric volume greater than 1.5 mL/kg.
No experimental treatment or additional invasive intervention will be administered as part of the study. If clinically relevant high-risk gastric findings are identified, the responsible anesthesia team will be informed and subsequent anesthetic management will be determined by the clinical team.
- Conditions
- Type 2 Diabetes Mellitus (DM), Gastric Ultrasound
- Being tested
- Preoperative Gastric Ultrasonography, Capillary Fasting Blood Glucose Measurement
- Keywords
- Gastric Ultrasonography, Preoperative Fasting, Residual Gastric Volume, Fasting Blood Glucose, Gastric Contents, Perlas Grading, Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Gastric UltrasonographyDiagnostic test
The gastric antrum will be evaluated in the supine and right lateral decubitus positions before anesthesia induction and sedative premedication. Gastric contents will be assessed qualitatively, and antral cross-sectional area and estimated residual gastric volume will be calculated quantitatively.
Capillary Fasting Blood Glucose MeasurementDiagnostic test
Capillary fasting blood glucose will be measured by fingertip sampling immediately before gastric ultrasonography. The measured glucose concentration will be evaluated as the primary exposure variable in relation to high-risk gastric findings.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Patients With Type 2 Diabetes Mellitus | Adult patients with type 2 diabetes mellitus, ASA physical status II or III, who are scheduled for elective surgery and undergo preoperative gastric ultrasonography and capillary fasting blood glucose measurement. Receives: Diagnostic Test: Preoperative Gastric Ultrasonography; Diagnostic Test: Capillary Fasting Blood Glucose Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a High-Risk Stomach
A high-risk stomach will be defined as the presence of at least one of the following findings on preoperative gastric ultrasonography: solid gastric contents; clear fluid visible in both the supine and right lateral decubitus positions (Perlas Grade 2); or an estimated gastric volume greater than 1.5 mL/kg.
Measured: On the day of surgery, during the preoperative assessment immediately before anesthesia induction
Secondary outcomes (16)
Association Between Age and High-Risk Stomach
Age will be recorded in years from the patient's medical record. The association between age and the presence of a high-risk stomach (yes/no) will be evaluated .
Measured: On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Sex and High-Risk Stomach
Sex will be recorded as male or female from the patient's medical record. The association between sex and the presence of a high-risk stomach (yes/no) will be evaluated.
Measured: On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Body Mass Index and High-Risk Stomach
Body mass index will be calculated as body weight in kilograms divided by height in meters squared and reported in kg/m². The association between body mass index and the presence of a high-risk stomach (yes/no) will be evaluated.
Measured: On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Duration of Type 2 Diabetes Mellitus and High-Risk Stomach
Duration of type 2 diabetes mellitus will be recorded in years based on the patient's medical history and medical records. Its association with the presence of a high-risk stomach (yes/no) will be evaluated.
Measured: On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Diabetes-Related Complications and High-Risk Stomach
The presence of diabetes related target organ complications will be determined from the patient's medical history and medical records and recorded as present or absent. The association between the presence of diabetes-related complications and a high-risk stomach (yes/no) will be evaluated.
Measured: On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Comorbidities and High-Risk Stomach
The presence of comorbidity will be assessed from the patient's medical history and medical records. Prespecified comorbidities will include hypertension, gastroesophageal reflux disease, obstructive sleep apnea, hypothyroidism, chronic kidney disease, dialysis treatment, and liver dysfunction. Participants will be classified according to the presence or absence of at least one of these comorbidities. The association between the presence of any prespecified comorbidity and a high-risk stomach (yes/no) will be evaluated.
Measured: On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Gastroparesis-Related Symptoms and High-Risk Stomach
Gastroparesis-related symptoms will be assessed by preoperative patient interview. Prespecified symptoms will include loss of appetite, early satiety, and postprandial fullness. Participants will be classified according to the presence or absence of at least one of these symptoms. The association between the presence of any gastroparesis-related symptom and a high-risk stomach (yes/no) will be evaluated.
Measured: On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Solid Food Fasting Duration and High-Risk Stomach
The time elapsed since the last solid food intake will be determined from the patient's history and clinical records and recorded in hours. Its association with the presence of a high-risk stomach (yes/no) will be evaluated.
Measured: On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Clear Fluid Fasting Duration and High-Risk Stomach
The time elapsed since the last clear fluid intake will be determined from the patient's history and clinical records and recorded in hours. Its association with the presence of a high-risk stomach (yes/no) will be evaluated.
Measured: On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Smoking Status and High-Risk Stomach
Smoking status will be assessed by patient interview and categorized as current smoker, former smoker, or never smoker. The association between smoking status and the presence of a high-risk stomach (yes/no) will be evaluated.
Measured: On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Antidiabetic Medication Use and High-Risk Stomach
Current antidiabetic medication use will be determined from the patient's medication history and medical records. Antidiabetic medications will include oral antidiabetic drugs, insulin, GLP-1 receptor agonists, and SGLT-2 inhibitors. Participants will be classified according to the presence or absence of current use of at least one antidiabetic medication. The association between any current antidiabetic medication use and the presence of a high-risk stomach (yes/no) will be evaluated.
Measured: On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Proton Pump Inhibitor Use and High-Risk Stomach
Proton pump inhibitor use will be determined from the patient's medication history and recorded as yes or no. Its association with the presence of a high-risk stomach (yes/no) will be evaluated.
Measured: On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between HbA1c and High-Risk Stomach
HbA1c will be obtained from routine preoperative laboratory results and recorded as a percentage (%). The association between HbA1c and the presence of a high-risk stomach (yes/no) will be evaluated.
Measured: On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Hemoglobin Level and High-Risk Stomach
Hemoglobin concentration will be obtained from routine preoperative laboratory results and recorded in g/dL. The association between hemoglobin concentration and the presence of a high-risk stomach (yes/no) will be evaluated.
Measured: On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Blood Urea Level and High-Risk Stomach
Blood urea concentration will be obtained from routine preoperative laboratory results and recorded in mg/dL. The association between blood urea concentration and the presence of a high-risk stomach (yes/no) will be evaluated.
Measured: On the day of surgery, during the preoperative assessment before anesthesia induction
Association Between Serum Creatinine Level and High-Risk Stomach
Serum creatinine concentration will be obtained from routine preoperative laboratory results and recorded in mg/dL. The association between serum creatinine concentration and the presence of a high-risk stomach (yes/no) will be evaluated.
Measured: On the day of surgery, during the preoperative assessment before anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (DM)Studies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma Cigdem Ozakin, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Fatma Çiğdem Özakın, MD, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842757
- Sponsor's protocol ID
- 2026/317
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kar Man Chan L. Gastric ultrasound: Enhancing preoperative risk assessment and patient safety. J Perioper Pract. 2025 Nov;35(11):501-503. doi: 10.1177/17504589241302220. Epub 2024 Dec 11.
PubMed 39663603Aydin BS, Guldogan IK. Determinants of gastric residual volume before elective surgery in diabetic patients: An observational study. Saudi J Anaesth. 2024 Apr-Jun;18(2):167-172. doi: 10.4103/sja.sja_339_23. Epub 2024 Mar 14.
PubMed 38654864Perlas A, Xiao MZX, Tomlinson G, Jacob B, Abdullah S, Kruisselbrink R, Chan VWS. Baseline Gastric Volume in Fasting Diabetic Patients Is Not Higher than That in Nondiabetic Patients: A Cross-sectional Noninferiority Study. Anesthesiology. 2024 Apr 1;140(4):648-656. doi: 10.1097/ALN.0000000000004815.
PubMed 37883294