Diabetes MellitusNCT01978886
Prevalence of Unknown and Known Diabetes in Patients With Frozen Shoulder
An observational study of Diabetes Mellitus and Frozen Shoulder, run by Sygehus Lillebaelt at 3 sites in Denmark.
Trial summary
The purpose of the study is to investigate how high the prevalence of diabetes (known and unknown) is among patients with a frozen shoulder. Our hypothesis is that it is around 30-40 %. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Frozen Shoulder
- How many people
- 220 participants
- Where
- 3 sitesDenmark
- Study dates
- Dec 2013to Feb 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All newly referred patients to one of the involved hospitals who is diagnosed with frozen shoulder.
Inclusion Criteria: All newly referred patients who is being diagnosed with frozen shoulder -
Exclusion Criteria: age below 25 or above 75, pt. who don't read or understand danish, not danish citizen, patients with mental illness, pt. with a abuse of alcohol or substances, pregnancy, pt. who within 4 months have been injected with adrenocortical hormone, arthrosis in the glenohumeral joint, avascular necrosis of caput humeri, rotator cuff lesion.
-
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Amager Hospital
Amager, Copenhagen, 2300
Sygehus Lillebaelt
Kolding, Kolding, 6000
Vejle Sygehus
Vejle, Vejle, 7100
About this study
The purpose of the study is to investigate how high the prevalence of diabetes (known and unknown) is among patients with a frozen shoulder. Our hypothesis is that it is around 30-40 %.
Another purpose is to investigate whether patients with diabetes have a worse and more painful frozen shoulder than patients without diabetes, and whether the diabetes have an influence on the prognosis.
Read the detailed description
Patients who are not diagnosed with diabetes would be ask to give a blood sample to investigate if they have an unknown diabetes.
All patients with frozen shoulder will be asked to fill out a questionnaire (Oxford Shoulder Score) to clarify how bad their frozen shoulder is. All patients will receive the questionnaire 6 and 24 month following the date on inclusion.
- Conditions
- Diabetes Mellitus, Frozen Shoulder
- Keywords
- Diabetes Mellitus, frozen shoulder, adhesive capsulitis
- Medical subject headings
- Diabetes Mellitus, Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient with diabetes | Patients who have been diagnoses with diabetes. | |
| Patients without diabetes | Patients who have not previous been diagnosed with diabetes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of known and unknown diabetes diabetes
Measured: 1 year
Secondary outcomes (1)
diabetes influence on the prognosis of frozen shoulder
how the status of diabetes influence the prognosis of frozen shoulder. The patient will be asked to fill out oxford shoulder score at the time of inclusion and at 6 and 24 months follow-up. The two groups (patients with and without diabetes) will be compared using the oxford shoulder score.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionFeb 2016
- Study completionFeb 2016
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 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sygehus Lillebaelt
- Sponsor type
- University, hospital or other
- Collaborators
- Amager Hospital
- Responsible party
- Principal investigator, per hviid gundtoft, Sygehus Lillebaelt
- Investigators
- per h gundtoft, md, Principal investigator, Sygehus Lillebaelt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978886
- Sponsor's protocol ID
- Gundtoft-01
- Status last verified
- Feb 2016
- First submitted
- 26 Oct 2013
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gundtoft PH, Attrup ML, Kristensen AK, Vobbe JW, Sorensen L, Holmich P. Diabetes mellitus affects the prognosis of frozen shoulder. Dan Med J. 2020 Sep 8;67(10):A02200071.
PubMed 33046203
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Unknown and Known Diabetes in Patients With Frozen Shoulder
- ClinicalTrials.gov ID
- NCT01978886
- Acronym / sponsor ID
- Gundtoft-01
- Conditions
- Diabetes Mellitus, Frozen Shoulder
- Keywords
- Diabetes Mellitus, frozen shoulder, adhesive capsulitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Sygehus LillebaeltUniversity, hospital or other
- Collaborators
- Amager Hospital
- Study start
- Dec 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Nov 2013 (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.
The purpose of the study is to investigate how high the prevalence of diabetes (known and unknown) is among patients with a frozen shoulder. Our hypothesis is that it is around 30-40 %.
Another purpose is to investigate whether patients with diabetes have a worse and more painful frozen shoulder than patients without diabetes, and whether the diabetes have an influence on the prognosis.
Detailed description
Patients who are not diagnosed with diabetes would be ask to give a blood sample to investigate if they have an unknown diabetes.
All patients with frozen shoulder will be asked to fill out a questionnaire (Oxford Shoulder Score) to clarify how bad their frozen shoulder is. All patients will receive the questionnaire 6 and 24 month following the date on inclusion.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with diabetes | – | –Patients who have been diagnoses with diabetes. |
| Patients without diabetes | – | –Patients who have not previous been diagnosed with diabetes. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All newly referred patients to one of the involved hospitals who is diagnosed with frozen shoulder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of known and unknown diabetes diabetes
Time frame: 1 year
1 secondary outcome
diabetes influence on the prognosis of frozen shoulder
Time frame: 24 months
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 11 Feb 2016.
- Derived from this study: PubMed 33046203Gundtoft PH, Attrup ML, Kristensen AK, Vobbe JW, Sorensen L, Holmich P. Diabetes mellitus affects the prognosis of frozen shoulder. Dan Med J. 2020 Sep 8;67(10):A02200071.
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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.
per h gundtoft, md principal investigator
Sygehus Lillebaelt
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Frozen Shoulder, run by Sygehus Lillebaelt at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
prevalence of known and unknown diabetes diabetes (time frame: 1 year). 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 NCT01978886, 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 11 Feb 2016.