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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
zufferey Pascal, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01420497
First received: August 18, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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 Intervention
Diabetes
Healthy
 Drug: intra-articular infiltration
Drug: epidural infiltration

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • glycemic values, [ Time Frame: day 0 to day 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • urinary excretion rate [ Time Frame: day 0 to day 15 ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: August 2008
Study Completion Date: June 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: methylprednisolone,infiltration Drug: intra-articular infiltration
intra articular infiltration
Active Comparator: epidural injection Drug: epidural infiltration
epidural infiltration

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420497

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

No publications provided

Responsible Party: zufferey Pascal, md, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT01420497     History of Changes
Other Study ID Numbers: gylperi
Study First Received: August 18, 2011
Last Updated: August 18, 2011
Health Authority: swissmedic: Switzerland

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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 18, 2013