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Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes.

NCT05909800 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2023-10-26

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Phenofibrate

Administred orally, once daily, for 12 months.

DRUG

Placebo

Administred orally, once daily, for 12 months.

Sponsors & Collaborators

  • Children's Memorial Health Institute, Poland

    collaborator OTHER

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Agnieszka Szypowska, MD, PhD,Prof · Medical University of Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-29
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05909800 on ClinicalTrials.gov