NCT03751839

Microarchitecture, Bone Strength and Fracture Risk in Long-term Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Christian Meier · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Biochemical Tests	The investigators will perform blood tests in every participant.
DIAGNOSTIC_TEST	Osteodensitometry	The investigators will perform an osteodensitometry in every participant.
DIAGNOSTIC_TEST	Clinical Tests	The investigators perform the following clinical tests: vibration threshold test, monofilament test, chair rise test and timed up and go test in every participant.
DIAGNOSTIC_TEST	HR-QCT	The investigators will perform HR-QCT measurements of the proximal femur and tibia in every participant.
DIAGNOSTIC_TEST	HR-pQCT	The investigators will perform HR-pQCT measurements of the distal radius and distal tibia in every participant.

Timeline

• Start date: 2018-10-01
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2018-11-23
• Last updated: 2021-07-27

Locations

1 site across 1 country: Switzerland