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
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
Universities (academic only)
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