None listed
Conditions
Brief summary
Peripheral neuropathy is one of the most common complications associated with type 2 diabetes and its effects can have major impact on pain, daily activities and quality of life. The primary aim of the project is to non-invasively evaluate nerve function and detect any changes over a one-year period among a group of people who are at high risk of developing diabetes (women with previous gestational diabetes mellitus) or at high risk of developing early and severe nerve complications from diabetes mellitus (people with early-onset type 2 diabetes mellitus). Women with previous gestational diabetes are at least a 7-fold higher risk of developing type 2 diabetes; and people with early onset type 2 diabetes are more likely to develop severe complications of diabetes (e.g. cardiovascular disease) some 15-30 years earlier than those with typical late onset type 2 diabetes. The sensitive nerve tests we propose to use will likely detect any changes in nerve function before they are apparent clinically. Early identification of nerve dysfunction will allow clinicians to proactively initiate early intervention and management in an effort to slow progression of nerve complications. Our proposed study has both quantitative and qualitative aspects. The quantitative aspect of the study will entail a prospective longitudinal evaluation of nerve conduction using established nerve excitability tests . This will comprise motor and sensory nerve excitability tests of the median nerve in the hand and a nerve conduction tests of the peroneal and sural nerves in the lower limb. The participants will be followed up at 6 months and 12 months and all tests will be repeated. We will also obtain information about participants' level of physical activity (using a questionnaire and a lightweight accelerometer), obtain HbA1c and fasting glucose. The qualitative part of the study will involve a 45-minute semi-structured interview, which will focus on the following topics: beliefs and understanding of nerve function in diabetes and what influences nerve complications; knowledge about signs and symptoms of nerve impairment; and knowledge of current exercise recommendations for health.
Interventions
Information for Participants will be submitted with ethics review, it provides information regarding the purpose of the study, procedure of the tests, and potential risk associated with the study.
The study includes using nerve excitability test to determine any chance in peripheral nerve function. Nerve excitability testing is a non-invasive electrophysiological technique that provides mechanistic information regarding the activity of ion channels, energy-dependent pumps and ion exchange proce
Information for Participants will be submitted with ethics review, it provides information regarding the purpose of the study, procedure of the tests, and potential risk associated with the study. The study includes using nerve excitability test to determine any chance in peripheral nerve function. Nerve excitability testing is a non-invasive electrophysiological technique that provides mechanistic information regarding the activity of ion channels, energy-dependent pumps and ion exchange processes activated during impulse conduction in peripheral nerve axons. Nerve excitability techniques have been used extensively to study biophysical properties of human peripheral nerves and have provided important physiological insight into axonal ion channel dysfunction in a wide spectrum of neurological disorders. This test will be repeated at 6 months and 12 months to determine any longitudinal changes in nerve function. The set up for nerve excitability test requires specialised equipment to run - including surface EMG, an electrical stimulator (DS5), a data acquisition system (National Instrument) and it only runs on Q-Trac software which is a license software. The most common tests are motor and sensory nerve excitability of the Median Nerve in hands. The study will also include interview with participants to obtain qualitative data. Yu Gu, a PhD student from University of Sydney, who is under the supervision of Dr Alison Harmer, Dr Michael Lee and A/Prof Sarah Dennis, will deliver the intervention. Dr Alison Harmer will oversee and supervise the whole project. Dr Lee has provided training and competency check on Miss Gu with operating the nerve excitability test, and A/Prof Dennis will provide advice and training on conducting interview and focus group. Miss Gu has a background in diabetic neuropathy research and has published an article titled "Are falls prevention programs effective at reducing the risk factors for falls in people with type-2 diabetes mellitus and peripheral neuropathy: A systematic review with narrative synthesis". Miss Gu is also practicing in Royal Prince Alfred Hospital in Sydney as a physiotherapist, and knows clinical practice ethics well. Both the nerve excitability test and the interview will be carried out in person. The nerve excitability will be conducted three times - at initial participation, 6 months follow up and 12 months follow up. Each time it will take approximately 1 hour, and will be conducted in the Brain and Mind Centre, University of Sydney. The interview will only be conducted once at the initial participation. It will take approximately 45 minutes and will be conducted in a conference room inside University of Sydney.
Sponsors
Yu Gu
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
For people who has an established diagnosis of type 2 diabetes mellitus - Need to be age 18-45 and was diagnosed before the age of 40 - Within 1-5 years of diagnosis Women with previous gestational diabetes - Not currently diagnosed with type 2 (or type 1) diabetes (HbA1c <6.5%, fasting glucose <7mmol/l) - At least one year after delivery and not currently breast feeding Control group - no diagnosis of diabetes and no family history of diabetes - HbA1c <5.7%, fasting glucose <5.6mmol/l - no neural disorders or conditions affecting nerves
Exclusion criteria
Carpal tunnel syndrome, cervical or lumbar radiculopathy
Outcome results
None listed