Fracture Risk After Pancreas Transplantation (FraPaT)

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Fractures, Bone Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Wounds and Injuries

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

San Raffaele Scientific Institute

Milan, Please Select, 20123, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pancreas transplantation alone

Procedure

Pancreas transplantation

Primary outcomes

Fracture incidence

Time frame: 02 January 2005 - 30 September 2018

Difference in fracture incidence (any fracture) between the PTA and the control group

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

Effect of Type 1 Diabetes Remission by Pancreas Transplantation Alone on Fracture Risk: a Retrospective Matched Cohort Study

Acronym: FRAPAT

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Mar 11, 2019
Registry last updated: Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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