P-295: Fenofibrate and preservation of β-cell function in children with newly diagnosed type 1 diabetes: a randomized, placebo-controlled trial
L Groele, M Dyminska, A Kowalska, T Wolniewicz, J Nowaczyk, A SzypowskaAbstract
Introduction
Type 1 diabetes is characterized by progressive β-cell loss. Modulation of sphingolipid metabolism has been proposed as a strategy to preserve residual insulin secretion.
Objectives
To evaluate whether fenofibrate preserves endogenous insulin secretion in children with newly diagnosed type 1 diabetes.
Methods
This double-blind, randomized, placebo-controlled trial was conducted at two centers in Warsaw, Poland. Children aged 10–17 years with T1D diagnosed within 8 weeks were randomized 1:1 to fenofibrate (160 mg daily) or placebo for 12 months. The primary endpoint was change in C-peptide area under the curve (AUC) during a mixed-meal tolerance test (MMTT). Analysis was performed using ANCOVA and mixed models for repeated measures (MMRM), adjusted for baseline covariates.
Results
Ninety-nine participants were randomized (placebo n=48; fenofibrate n=51). At 6 months, the decline in C-peptide AUC was smaller in the fenofibrate group (LS mean difference 0.179; 95% CI 0.016–0.341; p=0.031). At 12 months, the difference did not reach statistical significance (0.230; 95% CI −0.013–0.472; p=0.063), although a consistent trend toward preservation was observed. Similar patterns were seen for peak C-peptide (6 months: p=0.008; 12 months: p=0.058). Glycaemic control and insulin requirements were comparable between groups.
Conclusions
Fenofibrate showed a transient beneficial effect on β-cell function in children with newly diagnosed T1D, with significant preservation at 6 months but not sustained at 12 months. These findings support further investigation of sphingolipid-targeted therapies in type 1 diabetes.