NCT03390179

Brief Summary

The hyperglycemic response to surgery and the added effect of low-dose steroids (dexamethasone 4 to 8mg), and whether these differ in diabetics and nondiabetics remain unclear. Therefore, we prospectively evaluate the intraoperative and postoperative serum glucose concentrations in diabetics and nondiabetics that received intravenous steroid administration. This multicentre study include \> 250 patients.Primary endpoiunt was glucose concentration at H6 after surgery. Secondary endpoints were glucose concentration at H12 and at H24 and effect of anesthesia (regional anesthesia)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 4, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

December 28, 2017

Last Update Submit

July 4, 2019

Conditions

DiabetesHealthy

Keywords

diabetesanesthesiasurgeryglucose

Outcome Measures

Primary Outcomes (1)

  • glucose concentration

    6-8 hour

Secondary Outcomes (2)

  • glucose concentration

    12 hour

  • glucose concentraion

    24 hour

Study Arms (2)

diabetes

Patient with non insulin diabetes

Drug: Steroid Drug

control

Patient without diabete

Drug: Steroid Drug

Interventions

Steroid DrugDRUG

mesure of the glucose concentration

controldiabetes

Eligibility Criteria

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

Diabetes (non insulin) or healthy patient scheduled for surgery under anesthesia

You may qualify if:

  • elective surgery under anesthesia

You may not qualify if:

  • \< 50 kg
  • emergency
  • insulin therapy
  • cardiac surgery
  • refusal
  • hyperglycemia\> 2g/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cuvillon

Nîmes, Gard, 30000, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 28, 2017

First Posted

January 4, 2018

Study Start

September 4, 2017

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)