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Trial registered on ANZCTR


Registration number
ACTRN12617000318381p
Ethics application status
Not yet submitted
Date submitted
22/02/2017
Date registered
28/02/2017
Date last updated
28/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Nerve function over the course of one year in people with and without diabetes
Scientific title
Peripheral nerve function and neuropathy among people with or at high risk of type 2 diabetes mellitus
Secondary ID [1] 291253 0
None
Universal Trial Number (UTN)
U1111-1193-4054
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes mellitus 302182 0
gestational diabetes 302183 0
diabetic peripheral neuropathy 302184 0
Condition category
Condition code
Metabolic and Endocrine 301793 301793 0 0
Diabetes
Neurological 301809 301809 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 297283 0
Early Detection / Screening
Comparator / control treatment
We will recruit BMI-. age-, gender- and activity matched control volunteers who does not have a diagnose of diabetes mellitus and who does not have signs of pre diabetes. The control group will only undergo the nerve excitability test, without the need to participate in the interview.
Control group
Active

Outcomes
Primary outcome [1] 301198 0
Nerve excitability test - examining the motor nerve excitability of the median nerve in the hand

Timepoint [1] 301198 0
0 months, 6 months and 12 months
Primary outcome [2] 301216 0
Nerve conduction test of the peroneal nerve in the lower limb
Timepoint [2] 301216 0
0 month, 6 months and 12 months
Primary outcome [3] 301238 0
Nerve conduction test of the sural nerve in the lower limb
Timepoint [3] 301238 0
0 month, 6 months, and 12 months
Secondary outcome [1] 332014 0
interview data analysis - beliefs and understanding of nerve function in diabetes
Timepoint [1] 332014 0
0 months
Secondary outcome [2] 332059 0
Interview data analysis - what factors can influences nerve complications
Timepoint [2] 332059 0
0 month
Secondary outcome [3] 332060 0
Interview data analysis - participants' knowledge about signs and symptoms of nerve impairment
Timepoint [3] 332060 0
0 month
Secondary outcome [4] 332061 0
Interview data analysis - participants' knowledge of current exercise recommendations for health
Timepoint [4] 332061 0
0 month
Secondary outcome [5] 332063 0
HbA1c - this data will be collect from the diabetic centre when participants go for their regular follow up every 6 months. It will be measured using blood samples.
Timepoint [5] 332063 0
0 month, 6 months and 12 months
Secondary outcome [6] 332091 0
Physical activity using an accelerometer
- the accelerometer will be worn for 4 days, more than 10 hours each day, on 2 weekdays and 2 weekend days.
Timepoint [6] 332091 0
0 month and 6 months
Secondary outcome [7] 332092 0
fasting blood glucose
Timepoint [7] 332092 0
0 month, 6 months and 12 months
Secondary outcome [8] 332093 0
Nerve excitability test - examining the sensory nerve excitability of the median nerve in the hand
Timepoint [8] 332093 0
0 month, 6 months and 12 months
Secondary outcome [9] 332103 0
Physical activity using a questionnaire

- the Questionnaire will be the International Physical Activity Questionnaire, it is a validated questionnaire had have been widely used in relevant studies. It is not designed for this study.
Timepoint [9] 332103 0
0 month

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Carpal tunnel syndrome, cervical or lumbar radiculopathy

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The number of participants was determined from previous study examining peripheral neuropathy in type 1 diabetes mellitus.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7545 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 15433 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 295710 0
University
Name [1] 295710 0
University of Sydney
Address [1] 295710 0
University of Sydney, Faculty of Health Science
75 East Street
Lidcombe
NSW 2141
Country [1] 295710 0
Australia
Primary sponsor type
Individual
Name
Yu Gu
Address
University of Sydney, Faculty of Health Science
75 East Street
Lidcombe
NSW 2141
Country
Australia
Secondary sponsor category [1] 294557 0
None
Name [1] 294557 0
NA
Address [1] 294557 0
NA
Country [1] 294557 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 297012 0
Sydney Local Health District
Ethics committee address [1] 297012 0
Royal Prince Alfred Hospital
Missenden Rd, Camperdown NSW 2050
Ethics committee country [1] 297012 0
Australia
Date submitted for ethics approval [1] 297012 0
01/03/2017
Approval date [1] 297012 0
Ethics approval number [1] 297012 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72714 0
Miss Yu Gu
Address 72714 0
University of Sydney, Faculty of Health Science
75 East Street
Lidcombe
NSW 2141
Country 72714 0
Australia
Phone 72714 0
+61 406351281
Fax 72714 0
Email 72714 0
yugu5468@Uni.sydney.edu.au
Contact person for public queries
Name 72715 0
Miss Yu Gu
Address 72715 0
University of Sydney, Faculty of Health Science
75 East Street
Lidcombe
NSW 2141
Country 72715 0
Australia
Phone 72715 0
+61 406351281
Fax 72715 0
Email 72715 0
yugu5468@Uni.sydney.edu.au
Contact person for scientific queries
Name 72716 0
Miss Yu Gu
Address 72716 0
University of Sydney, Faculty of Health Science
75 East Street
Lidcombe
NSW 2141
Country 72716 0
Australia
Phone 72716 0
+61 406351281
Fax 72716 0
Email 72716 0
yugu5468@Uni.sydney.edu.au

No data has been provided for results reporting
Summary results
Not applicable