Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT02888951

Conditions

Diabetes

Diabetes Mellitus

Diabetes Mellitus Type 1

Diabetes Mellitus Type 2

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This study evaluates the amount of fluid remaining in the stomach of diabetic patients after a standard fasting period, and compare it with non-diabetic patients coming for elective surgical procedures.

Conditions

Diabetes

Diabetes Mellitus

Diabetes Mellitus Type 1

Diabetes Mellitus Type 2

Study ID

NCT02888951

Start date

Aug, 2016

Status verified date

Feb, 2019

Completion date

Jan, 2021

Anticipated

Primary completion date

Jan, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients scheduled for elective surgery aged 18 to 85 years
  • American Society of Anesthesia physical status classification I to III
  • Body mass index < 40 kg/ cm2.

Exclusion Criteria:

  • Pregnancy (currently or within the past 3 months)
  • Previous surgery of the upper gastrointestinal tract
  • Achalasia

Study Design

Enrollment

240 participants

Anticipated

Interventions and Outcome Measures

Arms

Diabetic Group

A group of diabetic patients who have fasted for at least 8 hours undergoing an elective surgical procedure.

Non-Diabetic Group

A group of non-diabetic patients who have fasted for at least 8 hours undergoing an elective surgical procedure.

Primary outcome measure

  • Volume of Gastric Contents [ Time Frame: Less than two hour prior to surgery ]

Central Contacts and Locations

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Principal Investigator:

Anahi Perlas, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jan 18, 2020

Last verified

Feb, 2019

Keywords

  • Diabetes
  • Diabetes Mellitus
  • Gastric Ultrasound
  • Preoperative fasting
  • Empty Stomach
  • Gastric Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2020-01-18.