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Fracture Risk After Pancreas Transplantation (FraPaT)

NCT ID: NCT03869281

Last Updated: 2020-12-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-07

Study Completion Date

2020-12-24

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 1 Fractures, Bone

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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PTA

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

Pancreas transplantation alone

Intervention Type PROCEDURE

Pancreas transplantation

Controls

outpatients with T1D attending the Endocrinology Unit at IRCCS San Raffaele Hospital and patients listed for a first deceased donor PTA

No interventions assigned to this group

Interventions

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Pancreas transplantation alone

Pancreas transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università Vita-Salute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Caterina Conte

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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San Raffaele Scientific Institute

Milan, Please Select, Italy

Site Status

Countries

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Italy

Other Identifiers

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155/INT/2018

Identifier Type: OTHER

Identifier Source: secondary_id

FRAPAT

Identifier Type: -

Identifier Source: org_study_id