Skip to main content
Clinical Trials/NCT03217630
NCT03217630
Completed
Not Applicable

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

West China Hospital1 site in 1 country108 target enrollmentJuly 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
West China Hospital
Enrollment
108
Locations
1
Primary Endpoint
Prevalence of full stomach
Status
Completed
Last Updated
7 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
April 30, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chunling Jiang

Professor

West China Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Prevalence of full stomach

Time Frame: 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 Outcomes

  • Mean gastric emptying time of clear liquid and light meal(one day)

Study Sites (1)

Loading locations...

Similar Trials