Genetic effects on cardiovascular response to fenofibrate in diabetes
Physiopathological Study of Genetic Modulation of Cardiovascular Effect of PPAR-Alpha Activation (MAGNETIC-PPARA)
This study is testing if a specific gene affects how well fenofibrate works for improving heart health in people with type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital Padova Academic / other |
| Locations | 1 site (Padova, Padua) |
| Trial ID | NCT05542147 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with type 2 diabetes who have experienced cardiovascular events or have at least one cardiovascular risk factor and are of European ancestry.
Not a fit: Patients with advanced chronic kidney disease, uncontrolled hypertension, or those with certain hereditary muscle disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with type 2 diabetes, optimizing the use of fenofibrate to prevent cardiovascular events.
How similar studies have performed: Previous studies have shown success in identifying genetic factors that influence drug response, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Padova, Padua
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.