Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel
Basel, Canton of Basel-City, 4031, Switzerland
NCT Number: NCT03751839
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.
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Notify Me40 year–80 year
All sexes
Interventional
Not applicable
Basel, Canton of Basel-City, 4031, Switzerland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The investigators will perform blood tests in every participant.
The investigators will perform an osteodensitometry in every participant.
Other names: dual energy x-ray absorptiometry (DXA scan)
The investigators perform the following clinical tests: vibration threshold test, monofilament test, chair rise test and timed up and go test in every participant.
The investigators will perform HR-QCT measurements of the proximal femur and tibia in every participant.
The investigators will perform HR-pQCT measurements of the distal radius and distal tibia in every participant.
Time frame: through study completion, an average of 6 months
measured by HR-pQCT at the distal radius and tibia
Time frame: through study completion, an average of 6 months
measured by HR-pQCT at the distal radius and tibia
Time frame: through study completion, an average of 6 months
a measure of bone strength, measured by HR-pQCT at the distal radius and tibia
Time frame: through study completion, an average of 6 months
a measure of bone strength, measured by HR-pQCT at the distal radius and tibia
Time frame: through study completion, an average of 6 months
measured by osteodensitometry (DXA)
Time frame: through study completion, an average of 6 months
measured by osteodensitometry
Time frame: through study completion, an average of 6 months
measured by osteodensitometry
Time frame: through study completion, an average of 6 months
a measure of bone texture, measured by osteodensitometry
Time frame: through study completion, an average of 6 months
the cortical thickness will be measured by pulse-echo ultrasound and high resolution quantitative computed tomography (HR-QCT)
Time frame: through study completion, an average of 6 months
the density weighed cortical thickness will be measured by pulse-echo ultrasound and HR- QCT
Time frame: through study completion, an average of 6 months
measured by HR-pQCT
Time frame: through study completion, an average of 6 months
biochemical marker of bone resorption
Time frame: through study completion, an average of 6 months
biochemical marker of bone formation
Time frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
Time frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
Time frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
Time frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
Time frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
Time frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
Time frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
Time frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
Time frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
Christian Meier
Other
Acronym: BOLD-1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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