Ultrasound Evaluation of Gastric Emptying in Diabetic Patients: a Comparison With Non-diabetic Controls

Completed

• Conditions: Diabetes Mellitus
• Interventions: Other: Fasting 2 h after clear liquid or 6h after a light meal

• Registration Number: NCT03217630
• Lead Sponsor: West China Hospital

Brief Summary

This is a prospective cohort study. The main objective is to compare the prevalence of a "full stomach" using gastric ultrasound technique, in elective surgical patients with diabetes mellitus compared to non-diabetic controls following the present fasting guidelines (2 h after clear liquid and 6h after a light meal). For patients with a full stomach or intermediate stomach, an consecutive ultrasound scan is performed every 10 min,until empty stomachstomach contents are detected to determine the mean gastric emptying time for clear liquid and light meal, and to investigate the risk factors for delayed stomach emptying in diabetic patients by logistic regression analysis .

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-07-09
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-14
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• diabetes (two fasting plasma glucose concentration≥7mmol/L or casual plasma glucose concentration≥11.1mmol/L);
• age≥18 yr; ASA physical status I-III;
• body mass index <35kg/m2;
• who are admitted to the surgical department;
• who are able to understand the rationale of the study and provide informed consent.

Exclusion Criteria

• pregnancy;
• a history of upper gastrointestinal disease or previous surgery on the oesophagus, stomach or upper abdomen;
• documented abnormalities of the upper gastrointestinal tract such as gastric tumors;
• recent upper gastrointestinal bleeding (within the preceding 1 month);
• taking medicines that may delay gastric emptying(e.g., anticholinergic agents).
• hypothyroidism.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-diabetic patients	Fasting 2 h after clear liquid or 6h after a light meal	-
Diabetic patients	Fasting 2 h after clear liquid or 6h after a light meal	-

Primary Outcome Measures

Name	Time	Method
Prevalence of full stomach	one day	The frequency of a "full stomach" in the diabetic population compared to a non-diabetic control population at 2h after ingesting clear liquid or 6h after light meal.

Secondary Outcome Measures

Name	Time	Method
Mean gastric emptying time of clear liquid and light meal	one day	The mean gastric emptying time of clear liquid and light meal in both diabetic and non-diabetic population.

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China