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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
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by zufferey Pascal, Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • glycemic values, [ Time Frame: day 0 to day 15 ]

Secondary Outcome Measures:
  • urinary excretion rate [ Time Frame: day 0 to day 15 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

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

Additional relevant MeSH terms:
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 16, 2017