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NCT01420497 Clinical Trial

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

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01420497
Other study ID # gylperi
Secondary ID
Status Completed
Phase N/A
First received August 18, 2011
Last updated August 18, 2011
Start date August 2008
Est. completion date June 2010

Study information
Verified date August 2011
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority swissmedic: Switzerland
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date June 2010
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- diabetes stable for more than ten days

- no contraindication for steroids

- lumbar stenosis

- articular pain

Exclusion Criteria:

- unstable diabetes

- renal insufficiency

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• intra-articular infiltration
intra articular infiltration
• epidural infiltration
epidural infiltration

Locations
Country Name City State
Switzerland CHUV Lausanne VD

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary glycemic values, day 0 to day 15 No
Secondary urinary excretion rate day 0 to day 15 No
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