Ignite Creation Date:
2024-05-06 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05219409
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-10
First Post:
2022-01-20
Brief Title:
Effects of Sitagliptin in Relatives of T1D Patients
Sponsor:
University of Milan
Organization:
University of Milan
Study Overview
Official Title:
Effects of Sitagliptin in Relatives of Patients With Type 1 Diabetes Mellitus at High Risk of Developing the Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SITA-one
Brief Summary:
Type 1 Diabetes T1D is a chronic autoimmune disease with a genetic background resulting from the immune-mediated destruction of beta cells of the pancreas It can lead to fatal short-term and long-term complications especially if it is diagnosed late Three stages of the disease can be identified Stage 1 is defined by the presence of two or more anti-islet autoantibodies GAD65 ICA IA-2 ZnT8 with normoglycemia Stage 2 shows progression to dysglycemia impaired glucose tolerance in the setting of two or more anti-islet autoantibodies Stage 3 occurs when a patient meets ADA criteria for the diagnosis of diabetes Its been demonstrated that Teplizumab an Fc receptor nonbinding anti-CD3 monoclonal antibody delays the transition from pre-symptomatic T1D stage 2 to overt T1D stage 3 Also Sitagliptin a DPP4 inhibitor has been proved effective in inhibiting inflammation in T1D both in vitro in T1D mice and in vivo in Latent autoimmune diabetes in adults LADA patients Furthermore it has been confirmed that Sitagliptin reduces the prevalence of worse forms of acute GVHD after myeloablative allogeneic hematopoietic stem-cell transplantation
The study aims to investigate if Sitagliptin can have a delaying effect on progression to overt T1D on the account of its anti-inflammatory properties The cohort is made of screened relatives of T1D patients who are classified as high-risk of developing T1D
Screening relatives of T1D patients for dysglycemia and anti-islet autoantibodies Selecting the patients in Stage 2 Pre-symptomatic T1D dysglycemia and at least two types of autoantibodies and then beginning therapy with Sitagliptin while monitoring their glucose metabolism with a Continuous Glucose Monitoring CGM system
The study aims to investigate if Sitagliptin can have a delaying effect on progression to overt T1D on the account of its anti-inflammatory properties The cohort is made of screened relatives of T1D patients who are classified as high-risk of developing T1D
Screening relatives of T1D patients for dysglycemia and anti-islet autoantibodies Selecting the patients in Stage 2 Pre-symptomatic T1D dysglycemia and at least two types of autoantibodies and then beginning therapy with Sitagliptin while monitoring their glucose metabolism with a Continuous Glucose Monitoring CGM system
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None