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

• Sponsor: Centre Hospitalier Universitaire Vaudois (Other)
• Overall Status: Completed
• CT.gov ID: NCT01420497
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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	Phase
Diabetes; Healthy	Drug: intra-articular infiltration; Drug: epidural infiltration	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. glycemic values, [day 0 to day 15]

Secondary Outcome Measures

1. urinary excretion rate [day 0 to day 15]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• diabetes stable for more than ten days

• no contraindication for steroids

• lumbar stenosis

• articular pain

Exclusion Criteria:

• unstable diabetes

• renal insufficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHUV	Lausanne	VD	Switzerland	1001

Sponsors and Collaborators

• Centre Hospitalier Universitaire Vaudois

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: zufferey Pascal, md, Centre Hospitalier Universitaire Vaudois
• ClinicalTrials.gov Identifier: NCT01420497
• Other Study ID Numbers: gylperi
• First Posted: Aug 19, 2011
• Last Update Posted: Aug 19, 2011
• Last Verified: Aug 1, 2011

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

Study Results

No Results Posted as of Aug 19, 2011