In short
Currently, there is 1 ongoing clinical trial investigating treatments for diabetic autonomic neuropathy, a condition where diabetes damages the nerves that control automatic body functions like heart rate and blood pressure. This trial is examining whether a medication called Finerenone can help slow or improve nerve damage affecting the heart and blood vessels in people with type 2 diabetes.
Clinical trial locations
Study on the Effects of Finerenone for Patients with Type 2 Diabetes and Early Diabetic Cardiovascular Autonomic Neuropathy
This trial, known as the FibroCAN study, is investigating how a medication called Finerenone might help people with type 2 diabetes who are experiencing early signs of nerve damage affecting their heart and blood vessels. This condition, called diabetic cardiovascular autonomic neuropathy, happens when high blood sugar levels damage the nerves that control the heart, leading to problems with heart rate and blood pressure regulation.
Main inclusion criteria:
- You must have type 2 diabetes as defined by the World Health Organization
- You must be 40 years of age or older
- You must have a specific abnormal heart function measurement called a pathological E/I ratio, which indicates early nerve damage
- You must be able to understand the study and provide informed consent
Main exclusion criteria:
- People without type 2 diabetes cannot participate
- People who do not have early-stage cardiovascular autonomic neuropathy cannot join
- People outside the specified age range are excluded
- Vulnerable populations who may have difficulty giving informed consent or who are at higher risk of harm cannot participate
Focus and goal of the trial:
The study aims to understand whether Finerenone can help modify the disease in its early stages by improving nerve function, reducing fibrosis (thickening and scarring of tissues), and decreasing inflammation in the body. The trial will last 78 weeks and uses a double-blind design, meaning neither participants nor researchers will know who is receiving the actual medication versus a placebo. This approach helps ensure unbiased results.
Throughout the study, participants will undergo various tests to assess nerve function, heart health, and levels of tissue scarring and inflammation. These include cardiovascular reflex tests, heart rate monitoring, blood tests, and skin biopsies performed at the start of the study and at weeks 36 and 78.
Investigational drug:
The medication being tested is Finerenone, which is taken orally as a film-coated tablet. Finerenone is a type of drug called a mineralocorticoid receptor antagonist, which works by blocking certain receptors in the body that can contribute to heart and kidney problems. By blocking these receptors, Finerenone may help reduce inflammation and tissue scarring, potentially improving how the heart and blood vessels function in people with diabetes-related nerve damage.
Summary
Currently, only one clinical trial is actively investigating treatments for diabetic autonomic neuropathy, specifically focusing on early-stage cardiovascular autonomic neuropathy in people with type 2 diabetes. This trial is being conducted in Denmark and is examining the potential benefits of Finerenone, a mineralocorticoid receptor antagonist, as a disease-modifying treatment. The study is particularly focused on understanding whether this medication can improve nerve function, reduce tissue scarring, and decrease inflammation over a 78-week treatment period. The findings from this research could provide valuable insights into new treatment approaches for managing this complication of diabetes.
