NCT01420497

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2011

Completed
Last Updated

August 19, 2011

Status Verified

August 1, 2011

Enrollment Period

1 month

First QC Date

August 18, 2011

Last Update Submit

August 18, 2011

Conditions

DiabetesHealthy

Keywords

methylprednisoloneintra articular infiltrationglycemiaepidural infiltrationdiabetes

Outcome Measures

Primary Outcomes (1)

  • glycemic values,

    day 0 to day 15

Secondary Outcomes (1)

  • urinary excretion rate

    day 0 to day 15

Study Arms (2)

methylprednisolone,infiltration

ACTIVE COMPARATOR
Drug: intra-articular infiltration

epidural injection

ACTIVE COMPARATOR
Drug: epidural infiltration

Interventions

intra-articular infiltrationDRUG

intra articular infiltration

methylprednisolone,infiltration
epidural infiltrationDRUG

epidural infiltration

epidural injection

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • unstable diabetes
  • renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1001, Switzerland

Location

Related Publications (1)

  • Zufferey P, Bulliard C, Gremion G, Saugy M, So A. Systemic effects of epidural methylprednisolone injection on glucose tolerance in diabetic patients. BMC Res Notes. 2011 Dec 21;4:552. doi: 10.1186/1756-0500-4-552.

    PMID: 22185681DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
md

Study Record Dates

First Submitted

August 18, 2011

First Posted

August 19, 2011

Study Start

August 1, 2008

Primary Completion

September 1, 2008

Study Completion

June 1, 2010

Last Updated

August 19, 2011

Record last verified: 2011-08

Locations

CH(1)