E10 E11
Conditions
Interventions
Group 1: 20 participants with type 1 diabetes and previous low-energy fractures
In all patients blood samples for routine parameters (blood count, kidney and liver function) as well as markers of th
Sponsors
Medizinische Universität Graz, Klinische Abteilung für Endokrinologie und Stoffwechsel
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Group I: Subjects with type 1 diabetes and previous low-energy fracture (T1withF), =18 years, established diabetes mellitus type 1 (>1 year) treated with insulin therapy, previous history of low-energy bone fracture/s, 25-hydroxyvitamin D =20 ng/ml achieved with or without Vitamin D supplementation; Group II: Subjects with type 1 diabetes without previous low-energy fracture (T1withoutF), Age=18 years, established diabetes mellitus type 1 (>1 year) treated with insulin therapy, 25-hydroxyvitamin D =20 ng/ml achieved with or without Vitamin D supplementation; Group III: Subjects with type 2 diabetes and previous low-energy fractures (T2withF), Age =18 years, established diabetes mellitus type 2 (>1 year) treated with any glucose lowering therapy except pioglitazone, previous history of low-energy bone fracture/s, 25 (OH) Vitamin D =20 ng/ml achieved with or without Vitamin D supplementation; Group IV: Subjects with type 2 diabetes without previous low-energy fractures (T2withF), Age =18 years, established diabetes mellitus type 2 (>1 year) treated with any glucose lowering therapy except pioglitazone, 25 (OH) Vitamin D =20 ng/ml achieved with or without Vitamin D supplementation;
Exclusion criteria
Exclusion criteria: Group I: osteoanabolic therapy, antiresorptive bone therapy; Group II: previous low-energy fractures and/or osteoprotective therapy; Group III: osteoanabolic therapy, antiresorptive bone therapy; Group IV: previous low-energy fractures and/or osteoprotective therapy; General exclusion criteria which apply for all of the aforementioned groups: 25 (OH) Vitamin D 40 kg/m2, pregnancy, severe renal impairment (estimated glomerular filtration <30 ml/min/1.73 m²) or current hemodialysis, medication with negative impact on bone (steroids, anabolics, pioglitazone etc.), secondary disorders of bone or mineral metabolism (Primary hyperparathyreoidism, Paget´s disease, osteogenesis imperfecta, osteomalacia), metallic implants on the non-dominant arm or both lower legs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective is the difference in body mass density between participants with type 1 and type 2 diabetes considering the presence or absence of a previous low-energy fracture and to compare bone mass density and structure assessed by HR-pQCT and DXA in individuals with type 1 diabetes and type 2 diabetes with and without previous low-energy fractures. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare ncRNA profiles in those with type 1 diabetes and type 2 diabetes with or without previous low-energy fractures. | — |
Countries
Austria
Contacts
Public ContactFelix Aberer
Medizinische Universität Graz, Klinische Abteilung für Endokrinologie und Stoffwechsel
Outcome results
None listed