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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]

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

gestational diabetes

diabetic peripheral neuropathy

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Neurological

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]

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]

Nerve excitability test - examining the motor nerve excitability of the median nerve in the hand

Timepoint [1]

0 months, 6 months and 12 months

Primary outcome [2]

Nerve conduction test of the peroneal nerve in the lower limb

Timepoint [2]

0 month, 6 months and 12 months

Primary outcome [3]

Nerve conduction test of the sural nerve in the lower limb

Timepoint [3]

0 month, 6 months, and 12 months

Secondary outcome [1]

interview data analysis - beliefs and understanding of nerve function in diabetes

Timepoint [1]

0 months

Secondary outcome [2]

Interview data analysis - what factors can influences nerve complications

Timepoint [2]

0 month

Secondary outcome [3]

Interview data analysis - participants' knowledge about signs and symptoms of nerve impairment

Timepoint [3]

0 month

Secondary outcome [4]

Interview data analysis - participants' knowledge of current exercise recommendations for health

Timepoint [4]

0 month

Secondary outcome [5]

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]

0 month, 6 months and 12 months

Secondary outcome [6]

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]

0 month and 6 months

Secondary outcome [7]

fasting blood glucose

Timepoint [7]

0 month, 6 months and 12 months

Secondary outcome [8]

Nerve excitability test - examining the sensory nerve excitability of the median nerve in the hand

Timepoint [8]

0 month, 6 months and 12 months

Secondary outcome [9]

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]

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

Sex

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

1/05/2017

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]

Royal Prince Alfred Hospital - Camperdown

Recruitment postcode(s) [1]

2050 - Camperdown

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Sydney

Address [1]

University of Sydney, Faculty of Health Science
75 East Street
Lidcombe
NSW 2141

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Sydney Local Health District

Ethics committee address [1]

Royal Prince Alfred Hospital
Missenden Rd, Camperdown NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/03/2017

Approval date [1]

Ethics approval number [1]

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

Miss Yu Gu

Address

University of Sydney, Faculty of Health Science
75 East Street
Lidcombe
NSW 2141

Country

Australia

Phone

+61 406351281

Fax

yugu5468@Uni.sydney.edu.au

Contact person for public queries

Name

Yu Gu

Address

University of Sydney, Faculty of Health Science
75 East Street
Lidcombe
NSW 2141

Country

Australia

Phone

+61 406351281

Fax

yugu5468@Uni.sydney.edu.au

Contact person for scientific queries

Name

Yu Gu

Address

University of Sydney, Faculty of Health Science
75 East Street
Lidcombe
NSW 2141

Country

Australia

Phone

+61 406351281

Fax

yugu5468@Uni.sydney.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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