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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

zufferey Pascal, Centre Hospitalier Universitaire Vaudois

ClinicalTrials.gov Identifier:

NCT01420497

First received: August 18, 2011

Last updated: NA

Last verified: August 2011

History: No changes posted

Tracking Information
First Received Date ^ICMJE	August 18, 2011
Last Updated Date	August 18, 2011
Start Date ^ICMJE	August 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 18, 2011)	glycemic values, [ Time Frame: day 0 to day 15 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: August 18, 2011)	urinary excretion rate [ Time Frame: day 0 to day 15 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Systemic Effects of Epidural Methylprednisolone Injection on Glucose Tolerance in Diabetic Patients
Official Title ^ICMJE	Not Provided
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
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Diabetes Healthy
Intervention ^ICMJE	Drug: intra-articular infiltration intra articular infiltration Drug: epidural infiltration epidural infiltration
Study Arm (s)	Active Comparator: methylprednisolone,infiltration Intervention: Drug: intra-articular infiltration Active Comparator: epidural injection Intervention: Drug: epidural infiltration
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	25
Completion Date	June 2010
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: diabetes stable for more than ten days no contraindication for steroids lumbar stenosis articular pain Exclusion Criteria: unstable diabetes renal insufficiency
Gender	Both
Ages	20 Years to 80 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Switzerland

Administrative Information
NCT Number ^ICMJE	NCT01420497
Other Study ID Numbers ^ICMJE	gylperi
Has Data Monitoring Committee	Yes
Responsible Party	zufferey Pascal, Centre Hospitalier Universitaire Vaudois
Study Sponsor ^ICMJE	Centre Hospitalier Universitaire Vaudois
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Centre Hospitalier Universitaire Vaudois
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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