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Prolonged Remission Induced by FENofibrate in children with newly diagnosed type 1 diabetes (PRIFEN): protocol of a
Lidia Groele1, Katarzyna Dżygało2, Agnieszka Kowalska2
1Department of Paediatrics, Medical University of Warsaw, Warsaw, Poland.
Insights
Fenofibrate may help maintain beta-cell function in children with new-onset type 1 diabetes (T1D). This study investigates if fenofibrate can prolong remission by activating sulfatide biosynthesis, crucial for pancreatic beta cells.
Area of Science:
- Endocrinology and Metabolism
- Immunology
- Pharmacology
Background:
- Sphingolipids, particularly sulfatides, play a role in pancreatic beta-cell function and apoptosis.
- Reduced sulfatide levels are implicated in the development of type 1 diabetes (T1D).
- Fenofibrate is known to activate sulfatide biosynthesis, suggesting a potential therapeutic role in T1D.
Purpose of the Study:
- To evaluate the clinical efficacy of fenofibrate in maintaining residual beta-cell function in children with newly diagnosed T1D.
- To assess if fenofibrate treatment can prolong the remission period in pediatric T1D patients.
- To investigate the impact of fenofibrate on key markers of beta-cell function and diabetes control.
Main Methods:
- A double-blind, randomized, placebo-controlled trial involving 102 children (10-17 years) with newly diagnosed T1D.
- Participants will receive either fenofibrate (160 mg daily) or a placebo for 12 months.
- The primary endpoint is the C-peptide area under the curve during a mixed-meal tolerance test (MMTT).
Main Results:
- The study is ongoing; results are not yet available.
- Secondary endpoints include C-peptide levels, diabetes control parameters, insulin requirements, and safety assessments.
- Genetic analysis and inflammation markers will also be assessed.
Conclusions:
- The findings will determine if fenofibrate is a viable option for preserving beta-cell function in T1D.
- This research could offer new insights into managing T1D and potentially prolonging its remission phase.
- Results will be disseminated through peer-reviewed publications and conference presentations.
Introduction:
Sphingolipids regulate proinsulin folding, insulin secretion and control beta cells apoptosis. Recent evidence has demonstrated that, among other factors, reduced amounts of sulfatide may be relevant in the development of type 1 diabetes (T1D). Thus, fenofibrate, which activates sulfatide biosynthesis, may prolong remission in subjects with T1D. The aim of the study is to evaluate clinical efficacy of fenofibrate on the maintenance of residual beta-cell function in children with newly diagnosed T1D.
Methods And Analysis:
A total of 102 children aged 10-17 years with newly diagnosed T1D will be enrolled in a double-blind, two-centre randomised, non-commercial, placebo-controlled trial. Subjects who will meet all inclusion criteria will be randomly assigned to receive fenofibrate at a dose of 160 mg or an identically appearing placebo, orally, once daily, for 12 months. The primary endpoint will be the area under the curve of the C-peptide level during 2-hour responses to a mixed-meal tolerance test (MMTT). Secondary endpoints include fasting and maximum C-peptide concentration in the MMTT, parameters of diabetes control and glucose fluctuations, daily insulin requirement, inflammation markers, genetic analysis, safety and tolerance of the fenofibrate ETHICS AND DISSEMINATION: The study protocol was approved by the Bioethics Committee. The results of this study will be submitted to a peer-reviewed diabetic journal. Abstracts will be submitted to international and national conferences.
Trial Registration Number:
EnduraCT 2020-003916-28.
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