Genetic effects on cardiovascular response to fenofibrate in diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how a specific genetic variant influences the cardiovascular response to fenofibrate, a medication used to treat dyslipidemia in patients with type 2 diabetes. Participants with different genotypes of the rs6008845 variant will be randomized to receive either fenofibrate or a placebo for 12 weeks. The study aims to validate previous findings regarding the genetic modulation of fenofibrate's effectiveness and to explore the underlying mechanisms through which this variant affects cardiovascular outcomes. By identifying the genetic factors that predict response to treatment, the study seeks to enhance precision medicine approaches in prescribing fenofibrate.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Type 2 diabetes with previous cardiovascular events or at least one CV risk factor (hypertension, obesity, smoke, age\>65 years)
* HbA1c \< 8%
* Triglycerides \< 200 mg/dl
* On statin treatments and with LDLcholesterol \< 100 mg/dl or at maximum statin-tolerated dose
* European ancestry (rational: given the relatively small sample size and the ancestry-differences in allele frequency of rs6008845 T allele \[i.e. from 65% in whites to 20% in blacks subjects) this criteria allows to limit ethnic-confounding factors that would reduce the probability of success of this physiopathological study aiming to dissect the mechanism of the genetic modulation of fenofibrate effectiveness).

Exclusion Criteria:

* CKD III stage with eGFR\<60 ml/min/1.73
* Uncontrolled hypertension with systolic blood pressure \> 170 mmHg at enrollment.
* Hereditary muscle disorders
* Uncontrolled hypothyroidism
* Elevated alcohol consumption
* Hepatic failure
* Allergy to fenofibrate or excipients
* Acute / chronic pancreatitis
* Pregnancy and lactation

Where it's running

• University Hospital of Padova
  Padova, Padua, Italy Recruiting

Study contacts

• Principal investigator: Mario Luca Morieri, MD PhD — University Hospital of Padova
• Study coordinator: Mario Luca Morieri, MD PhD
• Email: marioluca.morieri@aopd.veneto.it
• Phone: 00390498217094

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.