NCT03646916

Brief Summary

To study the effect of intra-operative dexamethasone on the management of post-operative blood sugar in diabetic patients.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_4 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
2.1 years until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

August 23, 2018

Last Update Submit

January 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post-operative blood sugar

    24 hour Post surgery

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR
Drug: DexamethasoneOther: No dexamethasone

Non-treatment

NO INTERVENTION

Interventions

Gluco-corticosteroid

Dexamethasone

Nothing

Dexamethasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • documented history of Type I or Type II Diabetes Mellitus
  • scheduled for surgery that requires patients to be admitted for at least 24 hours post-surgery

You may not qualify if:

  • Patients on steroid therapy
  • Pregnant women
  • Patients at low risk for nausea/vomiting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 24, 2018

Study Start

September 15, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations