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

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ClinicalTrials.gov Identifier: NCT01420497
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : August 19, 2011
Sponsor:
Information provided by (Responsible Party):
zufferey Pascal, Centre Hospitalier Universitaire Vaudois

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.

Condition or disease Intervention/treatment
Diabetes Healthy Drug: intra-articular infiltration Drug: epidural infiltration

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : August 2008
Primary Completion Date : September 2008
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: methylprednisolone,infiltration Drug: intra-articular infiltration
intra articular infiltration
Active Comparator: epidural injection Drug: epidural infiltration
epidural infiltration



Primary Outcome Measures :
  1. glycemic values, [ Time Frame: day 0 to day 15 ]

Secondary Outcome Measures :
  1. urinary excretion rate [ Time Frame: day 0 to day 15 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • unstable diabetes
  • renal insufficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420497


Locations
Switzerland
CHUV
Lausanne, VD, Switzerland, 1001
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: zufferey Pascal, md, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT01420497     History of Changes
Other Study ID Numbers: gylperi
First Posted: August 19, 2011    Key Record Dates
Last Update Posted: August 19, 2011
Last Verified: August 2011

Keywords provided by zufferey Pascal, Centre Hospitalier Universitaire Vaudois:
methylprednisolone
intra articular infiltration
glycemia
epidural infiltration
diabetes

Additional relevant MeSH terms:
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents