[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657580":3},{"organization":4,"outcomesModule":7,"designInfo":64,"detailedDescription":67,"studyPopulation":68,"armGroups":69,"interventions":76,"overallOfficials":86,"centralContacts":90,"locations":95,"responsibleParty":109,"collaborators":63,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":63,"eligibilityCriteria":118,"healthyVolunteers":114,"sex":119,"minAge":120,"maxAge":63,"enrollmentInfo":121,"targetDuration":63,"studyType":124,"phases":63,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":137,"whyStopped":63,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Bakirkoy Dr. Sadi Konuk Research and Training Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":63},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002Fkg.","On the day of surgery, during the preoperative assessment immediately before anesthesia induction",[14,18,21,24,27,30,33,36,39,42,45,48,51,54,57,60],{"measure":15,"description":16,"timeFrame":17},"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\u002Fno) will be evaluated .","On the day of surgery, during the preoperative assessment before anesthesia induction",{"measure":19,"description":20,"timeFrame":17},"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\u002Fno) will be evaluated.",{"measure":22,"description":23,"timeFrame":17},"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\u002Fm². The association between body mass index and the presence of a high-risk stomach (yes\u002Fno) will be evaluated.",{"measure":25,"description":26,"timeFrame":17},"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\u002Fno) will be evaluated.",{"measure":28,"description":29,"timeFrame":17},"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\u002Fno) will be evaluated.",{"measure":31,"description":32,"timeFrame":17},"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\u002Fno) will be evaluated.",{"measure":34,"description":35,"timeFrame":17},"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\u002Fno) will be evaluated.",{"measure":37,"description":38,"timeFrame":17},"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\u002Fno) will be evaluated.",{"measure":40,"description":41,"timeFrame":17},"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\u002Fno) will be evaluated.",{"measure":43,"description":44,"timeFrame":17},"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\u002Fno) will be evaluated.",{"measure":46,"description":47,"timeFrame":17},"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\u002Fno) will be evaluated.",{"measure":49,"description":50,"timeFrame":17},"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\u002Fno) will be evaluated.",{"measure":52,"description":53,"timeFrame":17},"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\u002Fno) will be evaluated.",{"measure":55,"description":56,"timeFrame":17},"Association Between Hemoglobin Level and High-Risk Stomach","Hemoglobin concentration will be obtained from routine preoperative laboratory results and recorded in g\u002FdL. The association between hemoglobin concentration and the presence of a high-risk stomach (yes\u002Fno) will be evaluated.",{"measure":58,"description":59,"timeFrame":17},"Association Between Blood Urea Level and High-Risk Stomach","Blood urea concentration will be obtained from routine preoperative laboratory results and recorded in mg\u002FdL. The association between blood urea concentration and the presence of a high-risk stomach (yes\u002Fno) will be evaluated.",{"measure":61,"description":62,"timeFrame":17},"Association Between Serum Creatinine Level and High-Risk Stomach","Serum creatinine concentration will be obtained from routine preoperative laboratory results and recorded in mg\u002FdL. The association between serum creatinine concentration and the presence of a high-risk stomach (yes\u002Fno) will be evaluated.",null,{"allocation":63,"interventionModel":63,"interventionModelDescription":63,"primaryPurpose":63,"observationalModel":65,"timePerspective":66,"maskingInfo":63},"COHORT","PROSPECTIVE","This is a single-center, prospective observational study involving adult patients with type 2 diabetes mellitus scheduled for elective surgery.\n\nOn 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.\n\nCapillary fasting blood glucose will be measured immediately before gastric ultrasonography and will constitute the primary independent variable.\n\nGastric 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.\n\nFor 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\u002Fkg.\n\nA 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\u002Fkg.\n\nNo 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.","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.",[70],{"label":71,"type":63,"description":72,"interventionNames":73},"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.",[74,75],"Diagnostic Test: Preoperative Gastric Ultrasonography","Diagnostic Test: Capillary Fasting Blood Glucose Measurement",[77,82],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":63},"DIAGNOSTIC_TEST","Preoperative Gastric Ultrasonography","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.",[71],{"type":78,"name":83,"description":84,"armGroupLabels":85,"otherNames":63},"Capillary Fasting Blood Glucose Measurement","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.",[71],[87],{"name":88,"affiliation":5,"role":89},"Fatma Çiğdem Özakın, MD","PRINCIPAL_INVESTIGATOR",[91],{"name":88,"role":92,"phone":93,"phoneExt":63,"email":94},"CONTACT","+905464168250","f.cigdemulus@gmail.com",[96],{"facility":97,"status":63,"city":98,"state":98,"zip":99,"country":100,"countryCode":63,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"Bakırköy Dr. Sadi Konuk Training and Research Hospital","Istanbul","34147","Turkey (Türkiye)",{"type":102,"coordinates":103},"Point",[104,105],28.94966,41.01384,{"lat":105,"lon":104},[108],{"name":88,"role":92,"phone":93,"phoneExt":63,"email":94},{"type":89,"investigatorFullName":110,"investigatorTitle":111,"investigatorAffiliation":5,"oldNameTitle":63,"oldOrganization":63},"Fatma Cigdem Ozakin","Principal Investigator, Anesthesiology and Reanimation Specialist, MD","100657580","preoperative-gastric-volume-and-high-risk-gastric-content-in-patients-with-type-2-diabetes-mellitus-100657580",false,"NCT07842757","Preoperative Gastric Volume and High-Risk Gastric Content in Patients With Type 2 Diabetes Mellitus","Clinical and Metabolic Determinants of High Residual Gastric Volume in Patients With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of type 2 diabetes mellitus\n* American Society of Anesthesiologists (ASA) physical status II or III\n* Scheduled for elective surgery\n* Suitable for preoperative gastric ultrasonography\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Body mass index ≥40 kg\u002Fm²\n* Emergency surgery\n* History of gastric, esophageal, or upper gastrointestinal surgery\n* Presence of a nasogastric tube\n* Known gastroparesis or gastric outlet obstruction\n* Active vomiting\n* Systemic opioid or prokinetic drug use within the previous 72 hours\n* Anatomical or technical conditions preventing adequate gastric ultrasonographic assessment\n* Impaired consciousness or inability to provide a reliable medical history\n* Refusal to participate in the study","ALL","18 Years",{"count":122,"type":123},120,"ESTIMATED","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.\n\nGastric 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.\n\nThe 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\u002Fkg.\n\nSecondary 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.",[127,128],"Type 2 Diabetes Mellitus (DM)","Gastric Ultrasound",[130,131,132,133,134,135,136],"Gastric Ultrasonography","Preoperative Fasting","Residual Gastric Volume","Fasting Blood Glucose","Gastric Contents","Perlas Grading","Type 2 Diabetes Mellitus","NOT_YET_RECRUITING","2026-09-26",{"date":140,"type":141},"2026-09-30","ACTUAL",{"date":143,"type":123},"2026-10-01",{"date":145,"type":123},"2027-04-01",{"name":5,"class":6},1]