Ultrasound Evaluation of Gastric Emptying in Diabetic Patients


Original post, click here

Verified June 2017 by Chunling Jiang, West China Hospital

Sponsor:

Information provided by (Responsible Party):

Chunling Jiang, West China Hospital

ClinicalTrials.gov Identifier:

NCT03187145

First received: June 12, 2017

Last updated: June 12, 2017

Last verified: June 2017

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.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Cohort Study of Ultrasound Evaluation of Gastric Emptying in Diabetic Patients: a Comparison With Healthy Controls

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment: 100
Anticipated Study Start Date: June 15, 2017
Estimated Study Completion Date: August 30, 2017
Estimated Primary Completion Date: July 30, 2017 (Final data collection date for primary outcome measure)
diabetic patients
healthy control

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Study participants will be diabetic patients whom are scheduled to undergo elective surgical procedures or heathy control. 100 patients will be recruited in total. One cohort consisting 50 patients will be diabetic (type 1 or 2). The other cohort consists of 50 healthy control.

Inclusion Criteria:

  • 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03187145

West China Hospital

Responsible Party: Chunling Jiang, Professor, West China Hospital
ClinicalTrials.gov Identifier: NCT03187145     History of Changes
Other Study ID Numbers: wch-160023
Study First Received: June 12, 2017
Last Updated: June 12, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

ClinicalTrials.gov processed this record on June 14, 2017