Diabetes Mellitus
Conditions
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 .
Interventions
OTHERFasting 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.
Sponsors
West China Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of full stomach | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean gastric emptying time of clear liquid and light meal | one day | The mean gastric emptying time of clear liquid and light meal in both diabetic and non-diabetic population. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Risk factors of delayed stomach empty in diabetic patients | one day | 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 |
Countries
China
Outcome results
None listed