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

August 18, 2011 updated by: zufferey Pascal, Centre Hospitalier Universitaire Vaudois
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • unstable diabetes
  • renal insufficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: methylprednisolone,infiltration
Drug: intra-articular infiltration
intra articular infiltration
ACTIVE_COMPARATOR: epidural injection
Drug: epidural infiltration
epidural infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
glycemic values,
Time Frame: day 0 to day 15
day 0 to day 15

Secondary Outcome Measures

Outcome Measure
Time Frame
urinary excretion rate
Time Frame: day 0 to day 15
day 0 to day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

August 18, 2011

First Posted (ESTIMATE)

August 19, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2011

Last Update Submitted That Met QC Criteria

August 18, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • gylperi

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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