The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.
This important study is investigating a medication called fenofibrate to see if it can help protect the eyes of adults living with Type 1 diabetes. Eye damage is a serious and feared complication of diabetes, and finding ways to prevent it is crucial. Fenofibrate is a medicine that helps lower fats in the blood and has previously shown promise in reducing eye damage in people with Type 2 diabetes. This research aims to find out if taking 145 mg of fenofibrate every day can offer similar protection for those with Type 1 diabetes who already have some early signs of eye changes. Around 450 adults will take part for about three years to see if this treatment can make a difference.
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¿De qué trata este estudio?
Diabetes is a condition that affects many parts of the body, and unfortunately, it's the most common reason why adults might lose their eyesight. Losing your sight can be very worrying, and doctors are always looking for ways to prevent this from happening.
This study is looking at a medicine called fenofibrate. This medicine is already used to help lower fats in the blood. Previous studies have shown that fenofibrate might help reduce eye damage in people with Type 2 diabetes. It has also shown positive results in protecting the eyes of animals with Type 1 diabetes.
The main goal of this research is to see if taking 145 mg of fenofibrate once a day can help prevent or slow down eye damage in adults who have Type 1 diabetes and some early signs of eye problems. Participants will be involved for about three years, and doctors will carefully monitor their eye health to see if the fenofibrate makes a difference. The study will compare those taking fenofibrate with those taking a dummy pill (placebo) to understand its real effects.
Puntos clave
- This study investigates if fenofibrate can protect eyes in Type 1 diabetes.
- Eye damage is a serious concern for people with diabetes.
- Fenofibrate is a daily tablet already used to lower fats in the blood.
- The study involves adults aged 18+ with Type 1 diabetes and early eye changes.
- Participation lasts about three years and includes regular eye checks.
¿Quién puede ser elegible?
To join this study, you need to be an adult aged 18 or older with Type 1 diabetes. Your diabetes diagnosis must meet specific criteria, which your doctor can help you understand. You also need to have healthy kidney function and some early signs of eye changes (called non-proliferative diabetic retinopathy), which will be checked with eye photographs.
There are also some reasons why you might not be able to join. For example, if you already have a clear need for or reason not to take fenofibrate, or if you need certain eye treatments within the next three months. Other medications for cholesterol, like statins, are generally allowed. The study is open to both men and non-pregnant women who are using reliable contraception.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- ¿Tienes 18 años o más?
- Do you have Type 1 diabetes?
- Do you have good kidney function?
- Have you been told you have early signs of eye changes from diabetes (non-proliferative retinopathy)?
- Are you able to attend regular clinic appointments?
¿En qué consiste la participación?
If you join this study, you will take either fenofibrate or a dummy pill (placebo) once a day for about three years. You will have regular appointments at the clinic for assessments, which will include eye checks and other health evaluations. It's important that you're able to come to these appointments and follow the study instructions carefully. Before you decide, you'll get detailed information about what's involved and will need to give your written consent.
Riesgos y beneficios potenciales
Locations (24)
- Canberra HospitalCódigo postal verificadoGarran, Australia
- Royal Prince Alfred HospitalCódigo postal verificadoCamperdown, Australia
- Concord Repatriation General HospitalCódigo postal verificadoConcord, Australia
- Garvan Institute of Medical ResearchCódigo postal verificadoDarlinghurst, Australia
- Retina Associates - South West RetinaCódigo postal verificadoLiverpool, Australia
- Hunter Diabetes CentreCódigo postal verificadoMerewether, Australia
- Prince of Wales HospitalCódigo postal verificadoRandwick, Australia
- Royal North Shore HospitalSolo ciudadSaint Leonards, Australia
- Cairns HospitalCódigo postal verificadoCairns, Australia
- Mater Adult HospitalCódigo postal verificadoSouth Brisbane, Australia
- Princess Alexandra HospitalCódigo postal verificadoWoolloongabba, Australia
- Royal Adelaide HospitalCódigo postal verificadoAdelaide, Australia
Preguntas comunes
What is Type 1 diabetes?
Type 1 diabetes is a condition where your body stops making insulin, a hormone needed to turn sugar into energy. People with Type 1 diabetes need to take insulin every day.
¿Qué es la retinopatía diabética?
Diabetic retinopathy is an eye condition that can happen to people with diabetes. High blood sugar levels can damage the small blood vessels in the retina, the light-sensing part at the back of your eye.
What is fenofibrate?
Fenofibrate is a medicine often used to lower high levels of fats (like cholesterol and triglycerides) in the blood. It's hoped it might also help protect eyes in people with diabetes.
Will I know if I'm getting the real medicine or the dummy pill?
No, this is a 'blinded' study, meaning neither you nor your doctor will know if you're taking fenofibrate or the placebo until the study is over. This helps ensure fair results.
¿Cuánto tiempo durará el estudio?
If you take part, you will be involved for approximately three years, with regular check-ups during that time.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.