ISRCTN - ISRCTN78698481: High Intensity Exercise Training in Type 2 Diabetes

Plain English Summary

Background and study aims
Recent information suggests that exercise may help people with type 2 diabetes improve their glucose control by increasing the ability of the body to burn fat, and increasing the sensitivity of the body to food. We aim to show the effect of exercise on sensitivity of the body to food, levels of fat in the liver and abdomen, and heart function.

Who can participate?
Men and Women aged between 30-70 years with Type 2 Diabetes, have a body mass index (BMI) between 25-35kg/m2 and who currently take part in no regular exercise.

What does the study involve?
You will be assigned to one of two groups. The first group will do three exercise sessions per week over 12 weeks. Each exercise session will involve you using a stationary cycle and resistance band, and will last about 40 minutes. A member of the research team will come with you on your first session to familiarise you with doing the exercises safely and after that an ipod with exercise tracks will guide you through the remaining sessions. Exercise will be held at a local gym which you choose and your gym membership will be paid for during the study. To maintain your weight throughout the study you will be given high calorie food supplements if your weight goes down by more than 1%. The second group will not do the exercise sessions or be required to undertake any exercise over the 12 weeks. If you are placed in this group, at the end of the study you will be given the opportunity to receive the exercise training, though this is not compulsory. Both groups will attend the Newcastle Magnetic Resonance Centre at the Newcastle General Hospital, or the Royal Victoria Infirmary on 5-9 occasions over 3 months. These visits include fasting blood tests, exercise tests, magnetic resonance scans and body composition measurements. You will wear a small device on your upper arm for 7 consecutive days before the 12 weeks and at the end to measure physical activity levels.

What are the possible benefits and risks of participating?
Being more physically active may be beneficial to the level of fat in your liver and if sustained after the study, may help in preventing other complications such as heart disease. You will have supervised exercise sessions which will teach you about your body, show you how to exercise correctly and help you become more physically fit. This study involves exercise so there are no side effects. Disadvantages of the study could be the time given up to participate and some people can experience claustrophobia (fear of confined spaces) in the magnetic resonance scan but if this happens we immediately stop the scan.

Where is the study run from?
The Institute of Cellular Medicine, Newcastle University.

When is the study starting and how long is it expected to run for?
The study started in September 2012 and aims to finish in September 2013.

Who is funding the study?
National Institute for Health Research Biomedical Research Centre for Ageing and Age Related Diseases.

Who is the main contact?
Sophie Cassidy
s.cassidy@newcastle.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Trenell

ORCID ID

Contact details

Newcastle Magnetic Resonance Centre
Campus for Ageing and Vitality
Newcastle Univeristy
Newcastle Upon Tyne
NE3 5JB
United Kingdom
+44 (0)191 248 1150
m.i.trenell@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of exercise on metabolism and liver lipid in people with non-alcoholic fatty liver disease (NAFLD)

Acronym

T2DHIT

Study hypothesis

The original hypothesis was that exercise would decrease liver fat independent of weight loss. Due to the clinically meaningful observations that were found during this study, those with more advanced glucose control problems were included to allow us to make comments about the impact of glucose control upon liver fat and cardiac function. It was hypothesized that exercise would improve glucose control, decrease liver fat and improve cardiac function in those with Type 2 Diabetes.

Ethics approval

All the procedures involved in this trial have been in accordance with institutional ethical standards and the Helsinki declaration. The original study received a favorable opinion from the Newcastle and North Tyneside 1 Research and Ethics Committee on the 07/10/2008. The Newcastle upon Tyne Hospitals Trust gave approval for the research to be conducted within the trust on 31/10/2008. The amended study was given approval by the Newcastle and North Tyneside 1 Research and Ethics Committee on the 17/04/2012 and the Newcastle upon Tyne Hospitals Trust on the 04/07/2012.

Study design

Single-site open-label randomized controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type 2 Diabetes

Intervention

The exercise group will be given a high intensity exercise prescription for 3 sessions per week for 12 weeks. Each session will include 40 minutes of mainly cycling exercise in which intensity will be individually tailored and monitored using the rate of perceived exertion scale. Exercise sessions will be conducted at the participant's local gym following familiarisation by a member of the research team.

The control group will their clinical care without any additional advice. They will be offered Exercise Counselling and Supervision similar to the treatment group at the end of their evaluation.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Glucose control (HbA1c)

Secondary outcome measures

1. Liver fat
2. Abdominal fat
3. Cardiac function
4. Resting and exercise metabolism (lipid oxidation)
5. Cytokine production
6. Insulin sensitivity
7. Physical Activity

Overall trial start date

01/09/2012

Overall trial end date

30/09/2013

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged between 30-70 years old
2. Diagnosed with Type 2 Diabetes which is metformin or diet controlled
3. BMI 25-35 kg/m2
4. Take part in no regular exercise

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

28

Participant exclusion criteria

1. The absolute and relative contraindications to exercise testing as stated by the American Heart Association (Fletcher et al., 2001)
2. Taking insulin/Sulfonylurea/ TZD/ Beta-blockers
3. Contraindications for MRI scanning
4. Heart or kidney disease
5. Undergoing dietary change

Recruitment start date

01/09/2012

Recruitment end date

30/09/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle Univeristy
Newcastle Upon Tyne
NE3 5JB
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor type

Hospital/treatment centre

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (UK) - Biomedical Research Centre for Ageing and Age Related Diseases

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data