Type 2 DiabetesNCT04765631
Type 2 Diabetes and Bone Microarchitecture
An observational study of Type 2 Diabetes, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Type 2 diabetes is a major public health problem, associated with an increased risk of fractures. Diabetes even appears to be the most important predictor of low kinetic fractures in men and women, and the risk of hip fracture in type 2 diabetics is increased by 40 to 50%, with often more serious consequences… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Patients with Type 2 diabetes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 582 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Jul 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Men and women included in the 3 cohorts (QUALYOR, OFELY, STRAMBO)
Who may be able to join
- Men and women included in the 3 cohorts (QUALYOR, OFELY, STRAMBO) presenting type 2 diabetes
- Age- and sex-matched control patients from the same cohorts without type 2 diabetes ; two control were age- and sex-matched to one type 2 diabetes patient.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site
INSERM U1033, pavillon F, Hôpital E. Herriot. 5, place d'Arsonval
Lyon, 69437
About this study
Official title: Type 2 Diabetes and Bone Microarchitecture in Men and Women: a Case-control Study
Type 2 diabetes is a major public health problem, associated with an increased risk of fractures. Diabetes even appears to be the most important predictor of low kinetic fractures in men and women, and the risk of hip fracture in type 2 diabetics is increased by 40 to 50%, with often more serious consequences (post-operative complications, longer hospital stays, increased mortality rate).
Currently, the risk of fractures is estimated by the measure of areal bone mineral density (aBMD) and T-score. However, in diabetics aBMD is not decreased, and even paradoxically increased. Indeed, aBMD is 5-10% higher in type 2 diabetic patients compared to non-diabetic subjects, which suggests that the assessment of fracture risk in these patients is underestimated. The High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) 3D bone imaging technique has a resolution close to the size of the bone trabeculae. It is used to assess volumetric bone mineral density (vBMD) and bone microarchitecture at the tibia and distal radius, and enables a better estimation of the fracture risk compared to the measurement of aBMD. Our hypothesis is that bone microarchitecture is altered in type 2 diabetic patients, explaining the increased risk of fracture in this population compared to non-diabetics.
We propose to set up a descriptive case control study, nestled in 3 cohorts of men and women (QUALYOR, OFELY and STRAMBO), to compare the bone micro-architecture measured by HR-pQCT at the level of the tibia and distal radius, in type 2 diabetics compared to non-diabetic subjects from the same cohorts.
- Conditions
- Type 2 Diabetes
- Being tested
- Patients with Type 2 diabetes, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with Type 2 diabetesOther
No intervention
PlaceboOther
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Patients with Type 2 diabetes | Subjects from 3 cohorts (QUALYOR, OFELY, STRAMBO) presenting type 2 diabetes Receives: Other: Patients with Type 2 diabetes | |
| Control subjects without Type 2 diabetes | Controls patients from 3 cohorts (QUALYOR, OFELY, STRAMBO) without type 2 diabetes Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome is the comparison of total volumetric bone mineral density (vBMD) at the tibia and distal radius, in type 2 diabetics compared to non-diabetic subjects.
The main outcome is the comparison of total volumetric bone mineral density (vBMD) measured by HR-pQCT at the tibia and distal radius, in type 2 diabetics compared to non-diabetic subjects from 3 cohorts of men and women (QUALYOR, OFELY, STRAMBO).
Measured: at inclusion for Qualyor patients. (the HRpQCT measure considered in this study is realised at the first visit just after inclusion of the patient for the Qualyor patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Jan 2020
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765631
- Sponsor's protocol ID
- Type 2 diabetes bone
- Status last verified
- Jul 2020
- First submitted
- 23 Jul 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 Diabetes and Bone Microarchitecture in Men and Women: a Case-control Study
- ClinicalTrials.gov ID
- NCT04765631
- Acronym / sponsor ID
- Type 2 diabetes bone
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 21 Feb 2021 (actual)
- 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.
Type 2 diabetes is a major public health problem, associated with an increased risk of fractures. Diabetes even appears to be the most important predictor of low kinetic fractures in men and women, and the risk of hip fracture in type 2 diabetics is increased by 40 to 50%, with often more serious consequences (post-operative complications, longer hospital stays, increased mortality rate).
Currently, the risk of fractures is estimated by the measure of areal bone mineral density (aBMD) and T-score. However, in diabetics aBMD is not decreased, and even paradoxically increased. Indeed, aBMD is 5-10% higher in type 2 diabetic patients compared to non-diabetic subjects, which suggests that the assessment of fracture risk in these patients is underestimated. The High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) 3D bone imaging technique has a resolution close to the size of the bone trabeculae. It is used to assess volumetric bone mineral density (vBMD) and bone microarchitecture at the tibia and distal radius, and enables a better estimation of the fracture risk compared to the measurement of aBMD. Our hypothesis is that bone microarchitecture is altered in type 2 diabetic patients, explaining the increased risk of fracture in this population compared to non-diabetics.
We propose to set up a descriptive case control study, nestled in 3 cohorts of men and women (QUALYOR, OFELY and STRAMBO), to compare the bone micro-architecture measured by HR-pQCT at the level of the tibia and distal radius, in type 2 diabetics compared to non-diabetic subjects from the same cohorts.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Type 2 diabetes | – | Other: Patients with Type 2 diabetesSubjects from 3 cohorts (QUALYOR, OFELY, STRAMBO) presenting type 2 diabetes |
| Control subjects without Type 2 diabetes | – | Other: PlaceboControls patients from 3 cohorts (QUALYOR, OFELY, STRAMBO) without type 2 diabetes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men and women included in the 3 cohorts (QUALYOR, OFELY, STRAMBO)
Key inclusion criteria (2 listed)
- Men and women included in the 3 cohorts (QUALYOR, OFELY, STRAMBO) presenting type 2 diabetes
- Age- and sex-matched control patients from the same cohorts without type 2 diabetes ; two control were age- and sex-matched to one type 2 diabetes patient.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Patients with Type 2 diabetesNo intervention | Other | Patients with Type 2 diabetes |
| PlaceboPlacebo comparator | Other | Control subjects without Type 2 diabetes |
Primary outcome
The main outcome is the comparison of total volumetric bone mineral density (vBMD) at the tibia and distal radius, in type 2 diabetics compared to non-diabetic subjects.
Time frame: at inclusion for Qualyor patients. (the HRpQCT measure considered in this study is realised at the first visit just after inclusion of the patient for the Qualyor patients)
The main outcome is the comparison of total volumetric bone mineral density (vBMD) measured by HR-pQCT at the tibia and distal radius, in type 2 diabetics compared to non-diabetic subjects from 3 cohorts of men and women (QUALYOR, OFELY, STRAMBO).
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 21 Feb 2021.
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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?
An observational study of Type 2 Diabetes, run by Hospices Civils de Lyon at 1 site in France.
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 2 inclusion and 1 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 21 Feb 2021. 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 France. 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?
The main outcome is the comparison of total volumetric bone mineral density (vBMD) at the tibia and distal radius, in type 2 diabetics compared to non-diabetic subjects. (time frame: at inclusion for Qualyor patients. (the HRpQCT measure considered in this study is realised at the first visit just after inclusion of the patient for the Qualyor patients)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2021.