You can now find the University's latest news, events and blogs at port.ac.uk/news-events-and-blogs

Diabetes study!

Research Title: To bathe or not to bathe?

Department: DSES

Nature of the study

The study will take place in the Spinnaker building of the University of Portsmouth and will involve 4 visits

Why are we conducting this research?

To see the effects of heating the body in blood sugar levels in people with type 2 diabetes.

What is already known?

Heating can reduce blood sugar levels in a similar way to exercise in people without diabetes. We want to see if this is the same in people with type 2 diabetes.

How many will be involved in the study?

We aim to recruit 20 people.

What would taking part involve?

The picture on the last page shows how the study will progress and what it will involve. In addition to this you will be required to wear a bathing suit and a t-shirt during the testing, including when you get out of the water. You will be towelled dry, given a blanket and the room will be kept warm so you won’t get cold. Changing facilities are provided.

What will happen once the study stops?

The results will be analysed and you will get and explanation of your results. The study’s findings will also aim to be published in a scientific journal and presented at scientific conferences. There will be no identifiable information used in publications or presentations.

Am I allowed to withdraw from the study once I have signed consent?

Yes, you are allowed to withdraw immediately, without reason. Withdrawal will not affect how you are treated, nor will it affect any treatment you are currently receiving.

What are the possible risks of taking part?

All risks have been kept to a minimum. The main burden will be spending an hour in the warm water as this may get uncomfortably warm. Additional discomfort my come from blood pressure measurements, the insertion of the cannula and the self-insertion of the rectal thermistor.

Additional information

Your GP will be informed of the study and whether you take part. Your picture may be taken for the purpose of conference presentations; however, all identifiable features will be blacked out. Snacks will be provided at the end of visits 2, 3 and 4. If you are willing, a brief interview will take place to help us learn about your experience, which will help improve future studies.

Who has reviewed this study?

This project has been reviewed by the [18/SC/0581] NRES Committee Hampshire A and it is registered on clinicaltrials.org

Thank you for reading this information leaflet. If you are interested in participating, what should you do?
This project is being run by Portsmouth University. The project organiser is Mr Thomas James a PhD student at the University of Portsmouth and will be using this study as part of his PhD research. If you would like to participate please contact our research team on 02392 842711 or email: thomas.james@port.ac.uk

Who can I ask about participation in research and how do I raise a complaint?
You should take time to consider your participation in the study and may discuss the project with your GP. The Patient Advice and Liaison Service (PALS) can provide independent advice about research participation, and can provide assistance if you have any concerns or complaints (Contact on: 02392 286 309 or PHT.PALS@porthosp.nhs.uk) or contact our sponsor at denise.teasdale@port.ac.uk for complaints.

Confidentiality and results?

We will be using information from your medical records and we are responsible for looking after your information and using it properly.

University of Portsmouth will keep identifiable information about you for 30 years after the study has finished. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate.

If you withdraw from the study, we will keep the information about you that we have already obtained.

You can find out more about how we use your information at www2.port.ac.uk/research/ethics. The University of Portsmouth will use your name, NHS number and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study.

Individuals from the University of Portsmouth may look at your medical and research records to check the accuracy of the research study.

QA Hospital will pass these details to University of Portsmouth along with the information collected from you and/or your medical records. The only people in University of Portsmouth who will have access to information that identifies you will be people who need to contact you to recruit and give information about the study to you or audit the data collection process.

What if something goes wrong?

In the unlikely event, negligent harm will be covered by the University of Portsmouth. No special arrangements have been made for non-negligent harm.

Volunteers must be:

  • Age: 35 years or older
  • Gender: Either
  • Staff/Student: Both

More Information:

  • Dates: 28/05/2019 to 01/01/2020
  • Duration: One, 2 hour visit followed by 3, 5 hour visits
  • Location: Spinnaker building

If you would like more information, contact Thomas James at thomas.james@port.ac.uk

Tel: 02392 842711
Ext: 2711

This testing has been reviewed by the Science Faculty ethics committee and been given the following ethics code: 18/SC/0581

UoP News © 2019 All Rights Reserved