Baseline Gastric Volume in Diabetic vs Non-Diabetic Patients

NCT07483593 | Not Yet Recruiting

• 1 other identifier: GOKAEK-2025/14/33
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Gastric Volume; Preoperative Fasting; Diabetes Mellitus

Keywords

Gastric Ultrasound; Gastric Volume; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

  Preoperative period

Secondary Outcomes (2)

• Association between diabetes severity and gastric volume

  Preoperative assessment

• Baseline gastric volume comparison

  Preoperative assessment

Study Arms (2)

Diabetic patients

Patients with diabetes mellitus scheduled for elective surgery undergoing preoperative gastric ultrasound assessment to measure baseline gastric volume.

Procedure: Gastric Ultrasound

Non-diabetic patients

Patients without diabetes mellitus scheduled for elective surgery undergoing preoperative gastric ultrasound assessment to measure baseline gastric volume.

Procedure: Gastric Ultrasound

Interventions

Gastric Ultrasound PROCEDURE

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.

Also known as: Preoperative Gastric Ultrasound

Diabetic patients; Non-diabetic patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Ages 18-75
• ASA I-III
• BMI ≤ 40 kg/m2

You may not qualify if:

• Patients with a history of gastrointestinal surgery,
• Pregnant women,
• Patients with documented abnormalities in the upper gastrointestinal tract, such as achalasia

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (2)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Sevim Cesur

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sevim CESUR, MD

  Kocaeli University

  STUDY DIRECTOR

Central Study Contacts

Sevim CESUR, MD

CONTACT

+902623038248; svmcsr@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)