Effect of fenofibrate on residual beta cell function in adults and adolescents with newly diagnosed type 1 diabetes: a randomised clinical trial
2024

Fenofibrate's Effect on Beta Cell Function in Type 1 Diabetes

Sample size: 58 publication 10 minutes Evidence: moderate

Author Information

Author(s): Hostrup Pernille E., Schmidt Tobias, Hellsten Simon B., Gerwig Rebekka H., Størling Joachim, Johannesen Jesper, Sulek Karolina, Hostrup Morten, Andersen Henrik U., Buschard Karsten, Hamid Yasmin, Pociot Flemming

Primary Institution: Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Herlev, Denmark

Hypothesis

The study aimed to investigate the efficacy and safety of fenofibrate in preserving beta cell function in adults and adolescents with newly diagnosed type 1 diabetes.

Conclusion

Fenofibrate does not support the preservation of beta cell function in individuals with newly diagnosed type 1 diabetes and may even increase beta cell stress.

Supporting Evidence

  • The fenofibrate group showed a higher PI/C ratio at week 52 compared to placebo.
  • Blood lipidome analysis revealed that fenofibrate repressed pathways involved in sphingolipid metabolism.
  • The intervention evoked few adverse events and no serious adverse events.

Takeaway

This study tested a medicine called fenofibrate to see if it could help people with a new type of diabetes keep their insulin-producing cells healthy, but it didn't work.

Methodology

A phase 2, placebo-controlled, double-blinded trial with 58 participants aged 16 to 40, randomized to receive fenofibrate or placebo for 52 weeks.

Potential Biases

No significant bias risks were reported.

Limitations

The study had a dropout rate of 14%, which may affect the statistical power, and the long remission phase could obscure small drug effects.

Participant Demographics

Participants were aged 16 to 40 years, with a mix of male and female individuals.

Statistical Information

P-Value

p<0.05

Confidence Interval

95% CI −0.05, 0.23

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1007/s00125-024-06290-6

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