Diabetes Mellitus, Type 1FRAPATNCT03869281
Fracture Risk After Pancreas Transplantation (FraPaT)
An observational study of Diabetes Mellitus, Type 1 and Fractures, Bone, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Fractures, Bone
- What is being tested?
- Pancreas transplantation alone
- Type of treatment
- Surgery or procedure
- How many people
- 81 participants
- Where
- 1 siteItaly
- Study dates
- 7 Dec 2019to 24 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Adult
Study population: All 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 will be screened for this study. Controls will be selected among outpatients with T1D attending the Endocrinology Unit at IRCCS San Raffaele Hospital and those listed for a first deceased donor PTA.
Who may be able to join
- 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
Show all 9Show fewer
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Type 1 Diabetes Remission by Pancreas Transplantation Alone on Fracture Risk: a Retrospective Matched Cohort Study
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.
Read more
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
- Being tested
- Pancreas transplantation alone
- Medical subject headings
- Diabetes Mellitus, Type 1, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreas transplantation aloneProcedure or surgery
Pancreas transplantation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Pancreas transplantation alone | |
| Controls | outpatients with T1D attending the Endocrinology Unit at IRCCS San Raffaele Hospital and patients listed for a first deceased donor PTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture incidence
Difference in fracture incidence (any fracture) between the PTA and the control group
Measured: 02 January 2005 - 30 September 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start7 Dec 2019
- Primary completion2 Mar 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caterina Conte, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869281
- Sponsor's protocol ID
- FRAPAT
- Other IDs
- 155/INT/2018
- Acronym
- FRAPAT
- Status last verified
- Dec 2020
- First submitted
- 8 Mar 2019
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Type 1 Diabetes Remission by Pancreas Transplantation Alone on Fracture Risk: a Retrospective Matched Cohort Study
- ClinicalTrials.gov ID
- NCT03869281
- Acronym / sponsor ID
- FRAPAT / FRAPAT
- Conditions
- Diabetes Mellitus, Type 1, Fractures, Bone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- 7 Dec 2019 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTA | – | Procedure: Pancreas transplantation alonepatients 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 |
| Controls | – | –outpatients with T1D attending the Endocrinology Unit at IRCCS San Raffaele Hospital and patients listed for a first deceased donor PTA |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Age groups
- Adult
- Study population
- All 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 will be screened for this study. Controls will be selected among outpatients with T1D attending the Endocrinology Unit at IRCCS San Raffaele Hospital and those listed for a first deceased donor PTA.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreas transplantation alonePancreas transplantation | Procedure or surgery | PTA |
Primary outcome
Fracture incidence
Time frame: 02 January 2005 - 30 September 2018
Difference in fracture incidence (any fracture) between the PTA and the control group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Fractures, Bone, run by Università Vita-Salute San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture incidence (time frame: 02 January 2005 - 30 September 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.