NCT03187145

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

July 12, 2017

Status Verified

June 1, 2017

Enrollment Period

2 months

First QC Date

June 12, 2017

Last Update Submit

July 9, 2017

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • the mean gastric emptying time of clear liquid and light meal

    one day

Other Outcomes (1)

  • Correlation of diabetes mellitus complications with delayed stomach empty

    one day

Study Arms (2)

diabetic patients

healthy control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study participants will be diabetic and non-diabetic patients whom are scheduled to undergo elective surgical procedures or heathy control. 150 participants will be recruited in total.

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnancy (currently or within the past 3 months) Previous surgery of the upper gastrointestinal tract Achalasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Chunling Jiang

CONTACT

+8602885423593jiang_chunling@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 12, 2017

First Posted

June 14, 2017

Study Start

June 15, 2017

Primary Completion

July 30, 2017

Study Completion

August 30, 2017

Last Updated

July 12, 2017

Record last verified: 2017-06

Locations

CN(1)