Status:
COMPLETED
Microarchitecture, Bone Strength and Fracture Risk in Long-term Type 1 Diabetes
Lead Sponsor:
Christian Meier
Collaborating Sponsors:
Insel Gruppe AG, University Hospital Bern
University Hospital Schleswig-Holstein
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- women and men with longstanding type 1 diabetes (age 40-80 years, BMI 18-37 kg/m2 and age- and sex matched non-diabetic controls
- presence of type 1 diabetes for at least 25 years (defined by history of Insulin treatment)
Exclusion
- Patients unable to give written informed consent, e.g. with severe dementia or patients not understanding German (or other local language)
- Any medical or psychiatric condition which would preclude the participant from adhering to the protocol
- Idiopathic or premenopausal osteoporosis or coexisting metabolic bone disease (e.g. Paget´s disease, primary hyperparathyroidism)
- Previous treatment with osteoporosis medication (bisphosphonates, denosumab) or intake of medications that are known to affect bone metabolism (e.g. steroids, anticonvulsants) within 6 months prior to enrollment
- Patients with medical conditions known to affect bone health ( e.g. metastatic bone disease, celiac disease, inflammatory bone disease, hypogonadism, thyrotoxicosis, hypercortisolism, chronic kidney disease stage IV and V (KDIGO), liver dysfunction (serum aspartate amino transferase (ASAT) \>3 times the upper limit of normal)
- Inability to keep the extremities still for a few minutes of an HR-pQCT examination (e.g. Parkinson disease, spastic syndrome)
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT03751839
Start Date
October 1 2018
End Date
July 1 2021
Last Update
July 27 2021
Active Locations (1)
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1
Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel
Basel, Canton of Basel-City, Switzerland, 4031