An observational study in Type 2 Diabetes Mellitus (DM) and Gastric Ultrasound, sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Observational
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.
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 120 is below the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Bakirkoy Dr. Sadi Konuk Research and Training Hospital is the lead sponsor of 122 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Preoperative Gastric Ultrasonography · Diagnostic Test: Capillary Fasting Blood Glucose Measurement
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 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.
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.
Time frame: On the day of surgery, during the preoperative assessment immediately before anesthesia induction
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 .
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: On the day of surgery, during the preoperative assessment before anesthesia induction
Plan to share: Undecided
Start is estimated for Oct 2026; primary completion for Apr 2027, 6 months later.
Of 432 non-industry observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 96. This study's planned 6 months is below that.
Counting every sponsor, half of 602 studies reached it within 32 months; a quarter within 17 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bakirkoy Dr. Sadi Konuk Research and Training Hospital →