Status:
COMPLETED
Fracture Risk After Pancreas Transplantation (FraPaT)
Lead Sponsor:
Università Vita-Salute San Raffaele
Conditions:
Diabetes Mellitus, Type 1
Fractures, Bone
Eligibility:
All Genders
18-64 years
Brief Summary
Individuals with type 1 diabetes (T1D) are at greater risk of fracture than non-diabetic subjects. Although the mechanisms underlying bone fragility in T1D are not completely understood, insulin defic...
Eligibility Criteria
Inclusion
- Inclusion Criteria (PTA group)
- T1D patients who received their first PTA, or second PTA only if their first graft was explanted within a week, between 2 January 2005 and 31 December 2017
- age ≥18 and \< 65 years
- willingness to participate in this observational study
- Inclusion Criteria (control group)
- Type 1 diabetes
- age ≥18 years and \< 65 years
- willingness to participate in this observational study
- minimum disease duration of 5 years
- brittle diabetes, as defined by the occurrence of frequent acute complications (ketoacidosis or severe hypoglycaemic episodes requiring third-part assistance or unawareness despite well-conducted intensive insulin therapy)
- presence of at least one diabetes-related complication (either neuropathy, retinopathy, subclinical nephropathy).
- Exclusion Criteria (both groups)
- conditions other than T1D known to affect bone health (i.e., non-compensated hypothyroidism, hyperthyroidism, hyperparathyroidism, inflammatory bowel disease, malignancy, rheumatoid arthritis, hypogonadism, severe chronic obstructive pulmonary disease, hepatic insufficiency, alcohol intake ≥ 3 units/day ),
- use of drugs that can affect bone metabolism (e.g., bisphosphonates, anticonvulsants, hormone replacement therapy) other than glucocorticoids and immunosuppressants
- recipients of simultaneous pancreas kidney transplantation, pancreatic islet transplantation, multiple PTAs, other transplants
- BMI \<18.5 or ≥ 30 kg/m2
Exclusion
Key Trial Info
Start Date :
December 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 24 2020
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT03869281
Start Date
December 7 2019
End Date
December 24 2020
Last Update
December 29 2020
Active Locations (1)
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1
San Raffaele Scientific Institute
Milan, Please Select, Italy, 20123