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NCT03187145 Clinical Trial

Ultrasound Evaluation of Gastric Emptying in Diabetic Patients

Diabetes Clinical Trial

Official title:
A Cohort Study of Ultrasound Evaluation of Gastric Emptying in Diabetic Patients: a Comparison With Healthy Controls

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03187145
Other study ID # wch-160023
Secondary ID
Status Recruiting
Phase N/A
First received June 12, 2017
Last updated July 9, 2017
Start date June 15, 2017
Est. completion date August 30, 2017

Study information
Verified date June 2017
Source West China Hospital
Contact Chunling Jiang
Phone +8602885423593
Email jiang_chunling@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a prospective cohort study. The main objective is to compare the frequency of a "full stomach" in the diabetic population compared to healthy controls 2 h after clear liquid and 6h after a light meal, and evaluate the mean gastric emptying time of clear liquid and light meal in diabetic patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date August 30, 2017
Est. primary completion date July 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Diabetic and non-diabetic Patients scheduled for elective surgery aged 18 to 85years 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

Related Conditions & MeSH terms

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 Correlation of diabetes mellitus complications with delayed stomach empty To assess whether there is significant correlation between diabetes mellitus related eye disease, cardiovascular cardiovascular autonomic neuropathy, peripheral neuropathy (MNSI) with delayed stomach empty one day
Primary Number of patients with full stomach The main objective is to compare the frequency of a "full stomach" in the diabetic population compared to a healthy control population 2h after clear liquid or 6h after light meal. one day
Secondary the mean gastric emptying time of clear liquid and light meal To assess the mean gastric emptying time of clear liquid and light meal in the diabetic population one day
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