Type 2 Diabetes Painful Peripheral Neuropathy study
Up to one third of people with diabetes develop nerve damage in the feet. This is known as peripheral neuropathy and can cause pain, weakness, the sensation of pins and needles or numbness.
This is prevalent in older people who have managed their diabetes for a long time. While high blood glucose levels can contribute, the reason people develop peripheral neuropathy is not yet fully understood.
A study led by Associate Professor Spiros Fourlanos at Royal Melbourne Hospital is trialling a new treatment for neuropathy.
A potential new treatment for Painful Peripheral Neuropathy
If the term ‘mitochondrial dysfunction’ means nothing to you, allow Associate Professor Fourlanos to explain:
“In patients with type 2 diabetes, the nerve cells often function normally at first.”
“Maintaining stable blood sugar levels can help with nerve cell function as it allows the nerve cells to use sugar optimally as an energy source.
“Mitochondria are the energy source of the cell, and it is understood that the dysfunction of mitochondria has a role in the development of neuropathy,” he continues.
“Mitochondrial dysfunction means that nerve cells cannot produce adequate energy.
“We believe treatment with a mitochondrial-based combination therapy can alleviate the dysfunction, which may reduce nerve function problems and reduce the pain sensation in people with diabetes.”
Pain is the most disturbing symptom of diabetic peripheral neuropathy, as it can be severe and even debilitating, and can lead to significant disability and impact on quality of life.
The possible benefits of this study include improvement or resolution of pain for participants. It could also result in changes to the future treatment of painful peripheral neuropathy.
Seeking type 2 participants for the Painful Peripheral Neuropathy Study
Associate Professor Fourlanos and his team of researchers are seeking support from the diabetes community. People aged 18 and over with type 2 diabetes who have been told by their doctor they have painful peripheral neuropathy are eligible for the study.
Participants will be required to:
- Take daily medications for 16 weeks.
- Attend two on-site visits at the Royal Melbourne Hospital (Parkville) at week 1 and week 16.
- Attend one phone appointment at week 8.
During the onsite visits, participants will undergo medical assessments such as physical/foot examinations, blood pressure, height, weight, blood tests and questionnaires will be completed at each of the three visits.
From lab to clinic
The concept of this study was developed by the late Professor Anthony Linnane, a world-renowned biochemist and molecular biologist celebrated for his work on mitochondrial genes and function. Associate Professor Fourlanos, in collaboration with Professor Linnane, conducted a previous pilot study which showed promising results.
Further funding from the Medical Research Future Fund (MRFF) and the Australian Centre for Accelerating Diabetes (ACADI) has enabled this larger study.
“The pilot trial achieved its primary outcome of significantly decreasing the pain score and anecdotally several patients reported a marked decrease in pain,” Associate Professor Fourlanos explains.
“Based on these observations and previous published scientific findings, we are investigating in this larger study if a mitochondrial-based combination therapy decreases nerve pain in people with diabetes. The study findings may also provide insights in to treating other mitochondrial disorders and other nerve disorders.”
Currently, there is no specific treatment to alter the course of progressive painful peripheral neuropathy.
It is treated symptomatically with anti-neuropathic medications as well as opioid or non-opioid analgesic medications.
“Treatment with this mitochondrial-based combination therapy may improve nerve function and in turn may improve nerve-related pain,” Associate Professor Fourlanos says.
Mitochondrial combination therapy in Type 2 Diabetes-Related Painful Peripheral Neuropathy
Site: Royal Melbourne Hospital, Parkville
- Principal Investigator: A/Prof Spiros Fourlanos, MBBS, FRACP, PhD
- Principal Coordinator: Dr Suzan Sam, BAppSc(Hons), PhD (suzan.sam@mh.org.au)
- Research Coordinator: Jane Sanders (Endocrine.Research@svhm.org.au)
Contact
Please contact Dr Suzan Sam if you have any queries by emailing diabetesendoresearch@mh.org.au.
Britt Denton
Communications and Media Lead
Brittany Denton is the Communications and Media Lead at Diabetes Victoria. She oversees media relations and communications, contributing to the organisation’s mission of supporting people with diabetes across the state.
