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.
En un coup d'œil
De quoi parle cette étude ?
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.
Points clés
- 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.
Qui peut être éligible ?
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.
Cet étude pourrait-elle vous convenir ?
Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.
- Avez-vous 18 ans ou plus ?
- 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)?
- Êtes-vous en mesure d'assister à des rendez-vous réguliers à la clinique ?
En quoi consiste la participation ?
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.
Risques et avantages potentiels
Locations (24)
- Canberra HospitalCode postal vérifiéGarran, Australia
- Royal Prince Alfred HospitalCode postal vérifiéCamperdown, Australia
- Concord Repatriation General HospitalCode postal vérifiéConcord, Australia
- Garvan Institute of Medical ResearchCode postal vérifiéDarlinghurst, Australia
- Retina Associates - South West RetinaCode postal vérifiéLiverpool, Australia
- Hunter Diabetes CentreCode postal vérifiéMerewether, Australia
- Prince of Wales HospitalCode postal vérifiéRandwick, Australia
- Royal North Shore HospitalVille uniquementSaint Leonards, Australia
- Cairns HospitalCode postal vérifiéCairns, Australia
- Mater Adult HospitalCode postal vérifiéSouth Brisbane, Australia
- Princess Alexandra HospitalCode postal vérifiéWoolloongabba, Australia
- Royal Adelaide HospitalCode postal vérifiéAdelaide, Australia
Questions fréquentes
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.
Qu'est-ce que la rétinopathie diabétique ?
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.
Combien de temps durera l'étude ?
If you take part, you will be involved for approximately three years, with regular check-ups during that time.
Comment en savoir plus
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
Discussion
Discussion communautaire
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