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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

August 18, 2011
August 18, 2011
August 2008
September 2008   (final data collection date for primary outcome measure)
glycemic values, [ Time Frame: day 0 to day 15 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
urinary excretion rate [ Time Frame: day 0 to day 15 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Systemic Effects of Epidural Methylprednisolone Injection on Glucose Tolerance in Diabetic Patients
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diabetes
  • Healthy
  • Drug: intra-articular infiltration
    intra articular infiltration
  • Drug: epidural infiltration
    epidural infiltration
  • Active Comparator: methylprednisolone,infiltration
    Intervention: Drug: intra-articular infiltration
  • Active Comparator: epidural injection
    Intervention: Drug: epidural infiltration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
June 2010
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • unstable diabetes
  • renal insufficiency
Both
20 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01420497
gylperi
Yes
zufferey Pascal, Centre Hospitalier Universitaire Vaudois
Centre Hospitalier Universitaire Vaudois
Not Provided
Not Provided
Centre Hospitalier Universitaire Vaudois
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP