Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05909800
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2022-11-29
Brief Title:
Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes
Sponsor:
Medical University of Warsaw
Organization:
Medical University of Warsaw
Study Overview
Official Title:
Randomized Double-blind Multicenter Parallel-group Placebo-controlled Study to Evaluate the Efficacy of Phenofibrate Treatment on the Functions of Beta Cells in Children and Adolescents With Newly Diagnosed of Type 1 Diabetes
Status:
RECRUITING
Status Verified Date:
2023-10
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:
PRIFEN
Brief Summary:
The goal of this clinical trial is to evaluate of the effect of phenofibrate on the functions of beta cells in children with new diagnosis of type 1 diabetes The main question it aims to answer is whether phenofibrate may prolong residual beta-cell function therefore own insulin secretion Participants will be asked to take a phenofibrate or identically appearing placebo a neutral substance orally once daily for 12 months with no knowledge what is administred to them They will be invited for follow-up visits including blood tests every 3 months Researchers will be monitoring the two groups for the safety of the phenofibrate and at the trial end they compare the residual insulin secretion results in two groups
Detailed Description:
Rationale
Preservation of residual pancreatic beta cell function in children with newly diagnosed T1D gives a chance for better diabetes control reduction of chronic diabetes complications and possibly temporary insulin withdrawal Indication of a cheap drug for secondary prevention of T1D
Setting
Recruitment will be through the paediatric diabetes clinics at two participating centres in Warsaw Poland Department of Paediatrics the Medical University of Warsaw and Department of Endocrinology and Diabetology Childrens Memorial Health Institute
The initiation of study treatment may be performed no later than 28 days after screening visit and no later than in 8 weeks from diabetes diagnosis
PICO
Adolescent participants meeting inclusion criteria newly diagnosed with type 1 diabetes will be randomly assigned to two groups receiving either fenofibrate at a dose of 160 mg or placebo and regularly assesed every 3 months for the next year Assuming increase by 50 of AUC of C-peptide in the test group compared to placebo 88 subjects are needed to achieve power of 85 If about 13 drop-out is assumed the total group size is 102 patients Given randomization ratio 11 there is 51 patients in each group
Main study procedures
Demographic and medical history
Physical examination and vital signs heart rate and blood pressure respiration rate body temperature
Blood collection for laboratory analysis hematology morphology with automatic blood smear biochemistry ALT AST total bilirubin albumin amylase lipase total cholesterol HDL LDL triglycerides GGTP HbA1c TSH FT4 Anti-Tg Anti-TPO CK creatinine urea vitamin D homocysteine Anti-tTG IgA IgA
Urine pregnancy test in girls with childbearing potential
C-peptide and Glucose in MMTT stimulation assay
Anti-insulin IAA antibodies Antibodies to glutamic acid decarboxylase GADA Antibodies to tyrosine phosphatase IA2A Antibodies to the zinc transporter 8 ZnT8
IL1 IL2 IL10
TNF alpha IFN gamma
Genetic study - WES genome sequencing HLA DR3 DR4 DO8 DQ7
FGM Libre Free Style Glucose Monitoring System
Abdominal ultrasound
Ultrasound of the thyroid gland
Safety monitoring and AE collection
IMP administration Compliance will be assessed by collecting empty packages as well as by direct interview and participants receiving 75 of the recommended doses will be considered as non-compliant
Preservation of residual pancreatic beta cell function in children with newly diagnosed T1D gives a chance for better diabetes control reduction of chronic diabetes complications and possibly temporary insulin withdrawal Indication of a cheap drug for secondary prevention of T1D
Setting
Recruitment will be through the paediatric diabetes clinics at two participating centres in Warsaw Poland Department of Paediatrics the Medical University of Warsaw and Department of Endocrinology and Diabetology Childrens Memorial Health Institute
The initiation of study treatment may be performed no later than 28 days after screening visit and no later than in 8 weeks from diabetes diagnosis
PICO
Adolescent participants meeting inclusion criteria newly diagnosed with type 1 diabetes will be randomly assigned to two groups receiving either fenofibrate at a dose of 160 mg or placebo and regularly assesed every 3 months for the next year Assuming increase by 50 of AUC of C-peptide in the test group compared to placebo 88 subjects are needed to achieve power of 85 If about 13 drop-out is assumed the total group size is 102 patients Given randomization ratio 11 there is 51 patients in each group
Main study procedures
Demographic and medical history
Physical examination and vital signs heart rate and blood pressure respiration rate body temperature
Blood collection for laboratory analysis hematology morphology with automatic blood smear biochemistry ALT AST total bilirubin albumin amylase lipase total cholesterol HDL LDL triglycerides GGTP HbA1c TSH FT4 Anti-Tg Anti-TPO CK creatinine urea vitamin D homocysteine Anti-tTG IgA IgA
Urine pregnancy test in girls with childbearing potential
C-peptide and Glucose in MMTT stimulation assay
Anti-insulin IAA antibodies Antibodies to glutamic acid decarboxylase GADA Antibodies to tyrosine phosphatase IA2A Antibodies to the zinc transporter 8 ZnT8
IL1 IL2 IL10
TNF alpha IFN gamma
Genetic study - WES genome sequencing HLA DR3 DR4 DO8 DQ7
FGM Libre Free Style Glucose Monitoring System
Abdominal ultrasound
Ultrasound of the thyroid gland
Safety monitoring and AE collection
IMP administration Compliance will be assessed by collecting empty packages as well as by direct interview and participants receiving 75 of the recommended doses will be considered as non-compliant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-003916-28 | EUDRACT_NUMBER | None | None |