NCT03217630

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

July 9, 2017

Last Update Submit

April 9, 2019

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Prevalence of full stomach

    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.

    one day

Secondary Outcomes (1)

  • Mean gastric emptying time of clear liquid and light meal

    one day

Other Outcomes (1)

  • Risk factors of delayed stomach empty in diabetic patients

    one day

Study Arms (2)

Diabetic patients

Other: Fasting 2 h after clear liquid or 6h after a light meal

Non-diabetic patients

Other: Fasting 2 h after clear liquid or 6h after a light meal

Interventions

Fasting 2 h after clear liquid or 6h after a light mealOTHER

The fasting time for all patients is 2 h after clear liquid or 6h after a light meal, then gastric ultrasound examination is performed.

Diabetic patientsNon-diabetic patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study participants will be diabetic and non-diabetic patients who are admitted to the surgical department and scheduled to undergo elective surgical procedures. 100 participants will be recruited in total.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

  • Zhou L, Yang Y, Yang L, Cao W, Jing H, Xu Y, Jiang X, Xu D, Xiao Q, Jiang C, Bo L. Point-of-care ultrasound defines gastric content in elective surgical patients with type 2 diabetes mellitus: a prospective cohort study. BMC Anesthesiol. 2019 Oct 10;19(1):179. doi: 10.1186/s12871-019-0848-x.

    PMID: 31601180DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Chunling Jiang

    West China Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 9, 2017

First Posted

July 14, 2017

Study Start

July 1, 2017

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations

CN(1)