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

Study Overview
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Brief Summary
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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 .

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Other: Fasting 2 h after clear liquid or 6h after a light meal


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic patients<br> | Other: Fasting 2 h after clear liquid or 6h after a light meal<br>* The fasting time for all patients is 2 h after clear liquid or 6h after a light meal, then gastric ultrasound examination is performed.<br>|
| Non-diabetic patients<br> | Other: Fasting 2 h after clear liquid or 6h after a light meal<br>* The fasting time for all patients is 2 h after clear liquid or 6h after a light meal, then gastric ultrasound examination is performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |