Trials / Completed
CompletedNCT03869281
Fracture Risk After Pancreas Transplantation (FraPaT)
Effect of Type 1 Diabetes Remission by Pancreas Transplantation Alone on Fracture Risk: a Retrospective Matched Cohort Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 81 (actual)
- Sponsor
- Università Vita-Salute San Raffaele · Academic / Other
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- —
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Pancreas transplantation alone | Pancreas transplantation |
Timeline
- Start date
- 2019-12-07
- Primary completion
- 2020-03-02
- Completion
- 2020-12-24
- First posted
- 2019-03-11
- Last updated
- 2020-12-29
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03869281. Inclusion in this directory is not an endorsement.