Fracture Risk After Pancreas Transplantation (FraPaT)

Completed

• Conditions: Diabetes Mellitus, Type 1; Fractures, Bone
• Interventions: Procedure: Pancreas transplantation alone

• Registration Number: NCT03869281
• Lead Sponsor: Università Vita-Salute San Raffaele

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 deficiency seems to play a key role.

To date, no information is available on the effect of diabetes remission after pancreatic transplantation alone (PTA) on the risk of fractures in T1D individuals with preserved kidney function.

The overall objective of this retrospective cohort study is to evaluate the effect of T1D remission after PTA on fracture risk.

The primary endpoint will be the difference in fracture incidence (any fracture) between the PTA group and the control group. For the PTA group, the incidence of fractures after transplantation will be considered.

Data from patients who underwent PTA at IRCCS San Raffaele Hospital from January 2, 2005 to December 31, 2017 will be compared with age-, gender- and disease duration-matched controls from the pool of outpatients with T1D attending the Endocrinology Unit at the same Institution. Anthropometric, anamnestic, laboratory data and data on the history of fractures and past/current therapies will be collected.

With this study, for the first time we will be able to obtain information on the effects of diabetes remission on the risk of fracture. We expect that the remission of diabetes will result in a beneficial effect on the fracture risk.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Study Start: 2019-12-07
• Primary Completion: 2020-03-02
• Status Verified: 2020-12
• Study Completion: 2020-12-24
• Last Update Submitted: 2020-12-27
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PTA	Pancreas transplantation alone	patients who underwent their first deceased donor PTA, or second deceased donor PTA if their first graft was explanted within a week, at the IRCCS San Raffaele Hospital between 2 January 2005 and 31 December 2017

Primary Outcome Measures

Name	Time	Method
Fracture incidence	02 January 2005 - 30 September 2018	Difference in fracture incidence (any fracture) between the PTA and the control group

Trial Locations

Locations (1)

San Raffaele Scientific Institute; 🇮🇹 Milan, Please Select, Italy