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Fracture Risk After Pancreas Transplantation (FraPaT)

NCT03869281 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2020-12-29

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1
  • Fractures, Bone

Interventions

PROCEDURE

Pancreas transplantation alone

Pancreas transplantation

Sponsors & Collaborators

  • Università Vita-Salute San Raffaele

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-07
Primary Completion
2020-03-02
Completion
2020-12-24

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03869281 on ClinicalTrials.gov