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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01228-43 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 diabetic population | Other | Bone biopsies |
|
| Non-diabetic control population | Other | Bone biopsies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone biopsies | Other | Bone biopsies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density | Bone mineral density (BMD) measured by Dual-energy X-ray absorptiometry (DXA) | 1 month after patient inclusion |
| Vertebral fractures | Presence of vertebral fractures evaluated by Vertebral Fracture Assessment (VFA) | 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 | 1 month after patient inclusion |
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Inclusion Criteria:
Exclusion Criteria:
Subjects treated with drugs known to interfere with bone metabolism, including steroids, anticonvulsants, diuretics, and bisphosphonates
Patients with severe renal disease (< 30 ml/mn); previous history of caner except skin cancer; myocardial infarction; uncontrolled hypertension; untreated hyperthyroidism; hyperthyroidism; malabsorption; bone metabolism diseases; rheumatoid arthritis or collagen diseases
Pregnant or lactating woman
Contraindication to taking tetracycline hydrochloride:
Psychiatric pathology seriously hampering understanding
Difficulty understanding oral French
Not a beneficiary of a social security scheme
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Edouard Herriot, Hospices Civisl de Lyon | Lyon | 69437 | France |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |