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| Name | Class |
|---|---|
| Insel Gruppe AG, University Hospital Bern | OTHER |
| University Hospital Schleswig-Holstein | OTHER |
| University Hospital, Basel, Switzerland | OTHER |
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This single center case control study will assess differences in bone structure between women and men with longstanding type 1 diabetes (diabetes duration>/= 25 years) and healthy controls.
Based on a cross-sectional approach the investigators aim to assess microstructural, biomechanical and densitometric bone characteristics in patients with longstanding type 1 diabetes and age- and sex-matches controls. The investigators examine whether the presence of microvascular disease and/or poor diabetic control is associated with an altered bone microarchitecture and whether any such effect is independent of bone mineral density. Furthermore, the investigators aim to look into the relationship between an altered bone microarchitecture and advanced glycation end product (AGE) formation as well as biochemical markers of bone formation and bone turnover. The study aims to identify type 1 diabetic patients with high fracture risk by assessing the discriminatory power of parameters of cortical and trabecular microstructure measured via high resolution peripheral quantitative computed tomography (HR-pQCT) of the distal radius and tibia and high resolution quantitative computed tomography (HR-QCT) of the proximal femur and tibia with and without adjustment for bone density.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic | Experimental | The investigators will examine all participants in the same way by performing biochemical tests, clinical tests, osteodensitometry, HRQCT and HRpQCT measurements. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biochemical Tests | Diagnostic Test | The investigators will perform blood tests in every participant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| volumetric bone mineral density in mg hydroxyapatite (HA)/ccm | measured by HR-pQCT at the distal radius and tibia | through study completion, an average of 6 months |
| cortical porosity in % | measured by HR-pQCT at the distal radius and tibia | through study completion, an average of 6 months |
| bone stiffness in kilonewton (kN)/mm | a measure of bone strength, measured by HR-pQCT at the distal radius and tibia | through study completion, an average of 6 months |
| failure load in kN | a measure of bone strength, measured by HR-pQCT at the distal radius and tibia | through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| areal bone mineral density of the spine in g/cm2 | measured by osteodensitometry (DXA) | through study completion, an average of 6 months |
| areal bone mineral density of the proximal femur in g/cm2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Meier, Prof. | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel | Basel | Canton of Basel-City | 4031 | Switzerland |
In the informed consent document participants can choose whether they agree to the further use of their coded data and biochemical material for future research purposes.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Identical diagnostic procedures will be performed in participants with type 1 diabetes and age- and sex-matched controls.
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| Osteodensitometry | Diagnostic Test | The investigators will perform an osteodensitometry in every participant. |
|
|
| Clinical Tests | Diagnostic Test | The investigators perform the following clinical tests: vibration threshold test, monofilament test, chair rise test and timed up and go test in every participant. |
|
| HR-QCT | Diagnostic Test | The investigators will perform HR-QCT measurements of the proximal femur and tibia in every participant. |
|
| HR-pQCT | Diagnostic Test | The investigators will perform HR-pQCT measurements of the distal radius and distal tibia in every participant. |
|
measured by osteodensitometry
| through study completion, an average of 6 months |
| areal bone mineral density of the distal radius in g/cm2 | measured by osteodensitometry | through study completion, an average of 6 months |
| trabecular bone score of the spine | a measure of bone texture, measured by osteodensitometry | through study completion, an average of 6 months |
| cortical thickness at the mid tibia in cm | the cortical thickness will be measured by pulse-echo ultrasound and high resolution quantitative computed tomography (HR-QCT) | through study completion, an average of 6 months |
| density weighed cortical thickness at the mid tibia in cm | the density weighed cortical thickness will be measured by pulse-echo ultrasound and HR- QCT | through study completion, an average of 6 months |
| bone marrow adiposity in mg/cm3 | measured by HR-pQCT | through study completion, an average of 6 months |
| measurement of serum carboxy-terminal collagen crosslinks (CTX) in pg/ml | biochemical marker of bone resorption | through study completion, an average of 6 months |
| measurement of serum n-terminal procollagen type 1 (P1NP) in mcg/l | biochemical marker of bone formation | through study completion, an average of 6 months |
| measurement of serum pentosidine in pmol/m | biochemical marker associated with bone fragility | through study completion, an average of 6 months |
| measurement of serum carboxymethyl-lysine (CML) in pmol/ml | biochemical marker associated with bone fragility | through study completion, an average of 6 months |
| measurement of serum insulin in mU/ml | biochemical marker associated with bone fragility | through study completion, an average of 6 months |
| measurement of serum sclerostin in pg/ml | biochemical marker associated with bone fragility | through study completion, an average of 6 months |
| measurement of serum adiponectin in ng/ml | biochemical marker associated with bone fragility | through study completion, an average of 6 months |
| measurement of serum insulin like growth factor -1 (IGF1) in nM | biochemical marker associated with bone fragility | through study completion, an average of 6 months |
| measurement of serum ultrasensitive c-reactive protein (usCRP) in mg/l | biochemical marker associated with bone fragility | through study completion, an average of 6 months |
| measurement of serum interleukin 6 (IL6) in pg/ml | biochemical marker associated with bone fragility | through study completion, an average of 6 months |
| measurement of serum periostin in ng/ml | biochemical marker associated with bone fragility | through study completion, an average of 6 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003720 |
| Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |