An interventional study of Bone biopsies in Type 2 Diabetes, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Other
Patients with type 2 diabetes have many complications in different organs. These complications are extremely frequent and severe: cardiovascular and renal disease, visual impairment, and, more recently, complications affecting bone such as fractures. Conventional methods for the evaluation of fracture risk are based on the Bone Mineral Density (BMD) or FRAX (algorithm for the prediction of osteoporotic fracture risk) are not sufficient in the context of diabetes. Several metaanalyses have shown that, paradoxically, a higher BMD in patients with type 2 diabetes compared to patients not suffering from this disease, independently of body mass index (BMI). The paradoxal increase in fracture risk, despite a high BMD has led to the hypothesis that diabetes induces a modification of the quality and not the quantity of bone. However, there is a lack of data as to bone quality in patients with type 2 diabetes as studies of bone biopsies from patients with type 2 diabetes are extremely rare.
The objective of the study is to compare bone quality in patients with type 2 diabetes to that in patients who do not suffer from type 2 diabetes: evaluation of vertebral fractures by osteodensitometry, measurement of Trabecular Bone Score (TBS), and analysis of bone quality in biopsies (advanced glycation end products (AGE), contents of bone matrix and analysis of mineralization).
The results will then be correlated with blood/urinary markers with the objective to determine one/several non-invasive biomarkers for bone status in diabetic patients.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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Exclusion Criteria:
Contraindication to taking tetracycline hydrochloride:
Bone biopsies
Other: Bone biopsies
Bone biopsies
Other: Bone biopsies
Bone biopsies
Bone mineral density
Bone mineral density (BMD) measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: 1 month after patient inclusion
Vertebral fractures
Presence of vertebral fractures evaluated by Vertebral Fracture Assessment (VFA)
Time frame: 1 month after patient inclusion
Trabecular Bone Score
Trabecular bone score (TBS) is a analytical tool that performs novel grey-level texture measurements on lumbar spine dual X-ray absorptiometry (DXA) images, and thereby captures information relating to trabecular microarchitecture
Time frame: 1 month after patient inclusion
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon