Study Results
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Basic Information
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COMPLETED
582 participants
OBSERVATIONAL
2020-01-01
2020-07-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Patients with Type 2 diabetes
Subjects from 3 cohorts (QUALYOR, OFELY, STRAMBO) presenting type 2 diabetes
Patients with Type 2 diabetes
No intervention
Control subjects without Type 2 diabetes
Controls patients from 3 cohorts (QUALYOR, OFELY, STRAMBO) without type 2 diabetes
Placebo
Placebo comparator
Interventions
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Patients with Type 2 diabetes
No intervention
Placebo
Placebo comparator
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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INSERM U1033, pavillon F, Hôpital E. Herriot. 5, place d'Arsonval
Lyon, , France
Countries
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Other Identifiers
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Type 2 diabetes bone
Identifier Type: -
Identifier Source: org_study_id
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