Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/05/2019
Date assigned
24/05/2019
Last edited
04/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
When people with Type 1 diabetes exercise, some experience hypoglycaemia (low blood sugar [glucose]), while others do not; in some HbA1c (a marker of diabetes control) gets worse while in others it improves. Exercise is known to increase glucose variability leading to more time with high and low levels. It is now known that many people with long-standing type 1 diabetes can produce small amounts of insulin from the remaining beta-cells in the pancreas. It is unknown if this is important for limiting blood glucose variability at rest and around exercise, and may explain some of the wide variation that is observed in response to exercise in people with Type 1 diabetes. This study aims to examine how residual beta-cell function impacts on glucose control when physically active / exercising in people with Type 1 diabetes.

Who can participate?
Anyone aged 18-65 years old with clinically diagnosed Type 1 diabetes, treated with exogenous insulin (pump or injection), free from diabetes complications can participate.

What does the study involve?
Participants will be required to complete a mixed meal tolerance test and a period of moderate intensity walking exercise for 45 minutes, with blood samples and interstitial glucose recorded before and after exercise

What are the possible benefits and risks of participating?
The benefits of taking part include understanding your own individual responses to exercise, receiving feedback on cardiovascular fitness, and contributing to the care and management of those with Type 1 diabetes. The risks of taking part include experiencing hypoglycaemia, musculoskeletal injury and muscle soreness.

Where is the study run from?
Newcastle upon Tyne NHS Foundation Trust, UK.

When is the study starting and how long is it expected to run for?
October 2016 to May 2019.

Who is funding the study?
1. Diabetes Research and Wellness Foundation, UK
2. Newcastle University, UK

Who is the main contact?
Dr Daniel West,
daniel.west@newcastle.ac.uk
Mr Gary Taylor,
g.taylor3@newcastle.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel West

ORCID ID

http://orcid.org/0000-0003-2246-4925

Contact details

Institute of Cellular Medicine
Room M4.077
William Leech Building
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
0191 2087076
daniel.west@newcastle.ac.uk

Type

Scientific

Additional contact

Mr Guy Taylor

ORCID ID

http://orcid.org/0000-0002-5207-1498

Contact details

Institute of Cellular Medicine
Room M4.077
William Leech Building
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
0191 2087076
G.Taylor3@newcastle.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

C-peptide and exercise in T1D V3 14/07/16

Study information

Scientific title

The role of residual beta-cell function on post-exercise glycaemic variability in individuals with type 1 diabetes

Acronym

Study hypothesis

Type 1 diabetes patients with residual beta-cell function demonstrate improved post-exercise glucose control

Ethics approval

Approved 02/09/2016 North East Tyne & Wear South Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Dr, Newcastle upon Tyne NE2 4NQ; 0207 104 8026; nrescommittee.northeast-tyneandwearsouth@nhs.net), ref: 16/NE/0192

Study design

Acute observational trial

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Type 1 diabetes

Intervention

Patients with Type 1 diabetes with a wide range of residual beta-cell function (from negative to clinically significant) will be recruited. Participants will be identified using urinary C-peptide Creatinine Ratio testing, and those eligible will complete a mixed meal tolerance test to establish maximal stimulated serum C-peptide concentrations. Participants will then complete a fixed bout of moderate intensity walking exercise at 60% VO2 peak for 45 minutes, with blood samples and interstitial glucose recorded before and after exercise.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The amount of time interstitial glucose is spent in euglycaemia measured using blinded interstitial continuous glucose monitoring

Secondary outcome measures

1. Glycaemic variability (SD, CV%, MAGE, J-Index, CONGA, MAG, M-value)
2. Time spent: hypoglycaemic (<3.9mmol/L, <3.0mmol/L), hyperglycaemic (>10mmol/L, >13.9mmol/L, >16.7mmol/L)
3. Hypoglycaemia stage 1 (<3.9mmol/L for 15+ minutes) and stage 2 (<3.0mmol/L for 15+ minutes) and hyperglycaemia incidence level 1 (>10mmol for 15+ minutes) and level 2 (>13.9mmol for 15+ minutes)
4. Corrective bolus/carbohydrate intake

Overall trial start date

01/08/2015

Overall trial end date

01/09/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18-65 years old
2. Clinically diagnosed Type 1 diabetes
3. Treated with exogenous insulin (pump or injection)
4. Free from diabetes complications

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Total final enrolment

30

Participant exclusion criteria

1. Type 1 diabetes participants duration of disease less than 1 year
2. HbA1c > 10% (86 mmol/mol)
3. Unable to complete maximal exercise test

Recruitment start date

01/10/2016

Recruitment end date

31/05/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle upon Tyne NHS Foundation Trust
Level 1 Regent Point Gosforth
Newcastle upon Tyne
NE3 3HD
United Kingdom

Sponsor information

Organisation

Newcastle University

Sponsor details

Faculty of Medical Sciences
The Medical School
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0)191 208 6000
kay.howes@ncl.ac.uk

Sponsor type

University/education

Website

https://www.ncl.ac.uk/

Funders

Funder type

Research organisation

Funder name

Diabetes Research and Wellness Foundation

Alternative name(s)

Diabetes Research and Wellness Foundation UK, DRWF

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

United Kingdom

Funder name

Newcastle University

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

01/01/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/06/2019: The total final enrolment was added. 21/05/2019: Trial’s existence confirmed by NHS Health Research Authority.