Microarchitecture, Bone Strength and Fracture Risk in Long-term Type 1 Diabetes
NCT ID: NCT03751839
Last Updated: 2021-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
136 participants
INTERVENTIONAL
2018-10-01
2021-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic
The investigators will examine all participants in the same way by performing biochemical tests, clinical tests, osteodensitometry, HRQCT and HRpQCT measurements.
Biochemical Tests
The investigators will perform blood tests in every participant.
Osteodensitometry
The investigators will perform an osteodensitometry in every participant.
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.
HR-QCT
The investigators will perform HR-QCT measurements of the proximal femur and tibia in every participant.
HR-pQCT
The investigators will perform HR-pQCT measurements of the distal radius and distal tibia in every participant.
Interventions
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Biochemical Tests
The investigators will perform blood tests in every participant.
Osteodensitometry
The investigators will perform an osteodensitometry in every participant.
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.
HR-QCT
The investigators will perform HR-QCT measurements of the proximal femur and tibia in every participant.
HR-pQCT
The investigators will perform HR-pQCT measurements of the distal radius and distal tibia in every participant.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* presence of type 1 diabetes for at least 25 years (defined by history of Insulin treatment)
Exclusion Criteria
* 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
40 Years
80 Years
ALL
Yes
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
University Hospital Schleswig-Holstein
OTHER
University Hospital, Basel, Switzerland
OTHER
Christian Meier
OTHER
Responsible Party
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Christian Meier
Prof. Dr. med. Christian Meier
Principal Investigators
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Christian Meier, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel
Basel, Canton of Basel-City, Switzerland
Countries
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Other Identifiers
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EKNZ 2018-01517
Identifier Type: -
Identifier Source: org_study_id
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