Systemic Effects of Epidural Methylprednisolone Injection... | NCT01420497

Studies
Systemic Effects of Epidural Methylprednisolone Injection on Glucose Tolerance in Diabetic Patients

NCT01420497

Sponsor

Centre Hospitalier Universitaire Vaudois

Status

Completed

Last Update Posted

Aug 19, 2011Estimated

Enrollment

25Actual

Phase

Not Applicable

Conditions

Diabetes
Healthy

Interventions

intra-articular infiltration
epidural infiltration

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Sep 2008Actual

Completion Date

Jun 2010Actual

First Submitted Date

Aug 18, 2011

First Submission Date that Met QC Criteria

Aug 18, 2011

First Posted Date

Aug 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2011

Last Update Posted Date

Aug 19, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

zufferey Pascal, md, Centre Hospitalier Universitaire VaudoisPrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire VaudoisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Several studies have shown that in diabetic patients, the glycemic profile was disturbed after intra-articular injection of corticosteroids. Little is known about the impact of epidural injection in such patients. The goal of this study was double, at first comparing the glycaemic profile in diabetic patients after a unique injection of 80 mg of acetate methylprednisolone either intra-articular or epidural, secondly to compare the amount of systemic diffusion of the drug the after both procedures.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
methylprednisolone,infiltration	Active Comparator		Drug: intra-articular infiltration
epidural injection	Active Comparator		Drug: epidural infiltration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intra-articular infiltration	Drug	intra articular infiltration	methylprednisolone,infiltration

Measure	Description	Time Frame
glycemic values,		day 0 to day 15

Measure	Description	Time Frame
urinary excretion rate		day 0 to day 15

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diabetes stable for more than ten days
no contraindication for steroids
lumbar stenosis
articular pain

Exclusion Criteria:

unstable diabetes
renal insufficiency

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHUV		Lausanne	Canton of Vaud	1001	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22185681	Derived	Zufferey P, Bulliard C, Gremion G, Saugy M, So A. Systemic effects of epidural methylprednisolone injection on glucose tolerance in diabetic patients. BMC Res Notes. 2011 Dec 21;4:552. doi: 10.1186/1756-0500-4-552.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases