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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03217630
• Other study ID #: 2017-141, 2018-56
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: April 2019
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Risk factors of delayed stomach empty in diabetic patients	Correlation between the latest fast, postprandial plasma glucose concentration, hemoglobin A1c level and the diabetes complications ( peripheral neuropathy, cardiovascular autonomic neuropathy, diabetic nephropathy,and diabetes mellitus-related eye disease (including diabetic retinopathy, macular edema, rubeosis iridis, vitreous hemorrhage and diabetic related-visual injury)) with delayed stomach empty	one day
Primary	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	Mean gastric emptying time of clear liquid and light meal	The mean gastric emptying time of clear liquid and light meal in both diabetic and non-diabetic population.	one day