DiabetesNCT01420497
Systemic Effects of Epidural Methylprednisolone Injection on Glucose Tolerance in Diabetic Patients
A study testing intra-articular infiltration and epidural infiltration in people with Diabetes and Healthy, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- What is being tested?
- intra-articular infiltration and epidural infiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2008to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diabetes stable for more than ten days
- no contraindication for steroids
- lumbar stenosis
- articular pain
Who cannot join
- unstable diabetes
- renal insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- intra-articular infiltration, epidural infiltration
- Keywords
- methylprednisolone, intra articular infiltration, glycemia, epidural infiltration, diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-articular infiltrationDrug
intra articular infiltration
epidural infiltrationDrug
epidural infiltration
| Study group | Role | What they receive |
|---|---|---|
| methylprednisolone,infiltration | Active comparator | Not described Receives: Drug: intra-articular infiltration |
| epidural injection | Active comparator | Not described Receives: Drug: epidural infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic values,
Measured: day 0 to day 15
Secondary outcomes (1)
urinary excretion rate
Measured: day 0 to day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startAug 2008
- Primary completionSep 2008
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zufferey Pascal, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420497
- Sponsor's protocol ID
- gylperi
- Status last verified
- Aug 2011
- First submitted
- 18 Aug 2011
- Last updated
- 19 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22185681
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Effects of Epidural Methylprednisolone Injection on Glucose Tolerance in Diabetic Patients
- ClinicalTrials.gov ID
- NCT01420497
- Acronym / sponsor ID
- gylperi
- Keywords
- methylprednisolone, intra articular infiltration, glycemia, epidural infiltration, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 19 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylprednisolone,infiltration | Active comparator | Drug: intra-articular infiltration |
| epidural injection | Active comparator | Drug: epidural infiltration |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diabetes stable for more than ten days
- no contraindication for steroids
- lumbar stenosis
- articular pain
Key exclusion criteria (2 listed)
- unstable diabetes
- renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intra-articular infiltrationintra articular infiltration | Drug | methylprednisolone,infiltration |
| epidural infiltrationepidural infiltration | Drug | epidural injection |
Primary outcome
glycemic values,
Time frame: day 0 to day 15
1 secondary outcome
urinary excretion rate
Time frame: day 0 to day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2011.
- Derived from this study: PubMed 22185681Zufferey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra-articular infiltration and epidural infiltration in people with Diabetes and Healthy, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycemic values, (time frame: day 0 to day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01420497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2011.