Do the remaining insulin-producing cells in people with type 1 diabetes help to maintain good glucose control after exercise?
| ISRCTN | ISRCTN50072340 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50072340 |
| Secondary identifying numbers | C-peptide and exercise in T1D V3 14/07/16 |
- Submission date
- 15/05/2019
- Registration date
- 24/05/2019
- Last edited
- 14/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Scientific
Institute of Cellular Medicine
Room M4.077
William Leech Building
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
 ORCID ID |
0000-0003-2246-4925 |
|---|---|
| Phone | 0191 2087076 |
| daniel.west@newcastle.ac.uk |
Scientific
Institute of Cellular Medicine
Room M4.077
William Leech Building
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
| ORCID ID |
0000-0002-5207-1498 |
|---|---|
| Phone | 0191 2087076 |
| G.Taylor3@newcastle.ac.uk |
Study information
| Study design | Acute observational trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The role of residual beta-cell function on post-exercise glycaemic variability in individuals with type 1 diabetes |
| Study hypothesis | Type 1 diabetes patients with residual beta-cell function demonstrate improved post-exercise glucose control |
| Ethics approval(s) | 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 |
| 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 |
| 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 study start date | 01/08/2015 |
| Overall study end date | 01/09/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| 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 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
- England
- United Kingdom
Study participating centre
Regent Point
Gosforth
Newcastle upon Tyne
NE3 3HD
United Kingdom
Sponsor information
University/education
Faculty of Medical Sciences
The Medical School
Framlington Place
Newcastle upon Tyne
NE2 4HH
England
United Kingdom
| Phone | +44 (0)191 208 6000 |
|---|---|
| kay.howes@ncl.ac.uk | |
| Website | https://www.ncl.ac.uk/ |
"ROR" |
https://ror.org/01kj2bm70 |
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Diabetes Research & Wellness Foundation, Diabetes Research and Wellness Foundation UK, DRWF
- Location
- United Kingdom
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2020 | 05/10/2020 | Yes | No |
| Results article | 10/03/2022 | 14/06/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
14/06/2023: Publication reference added.
04/06/2019: The total final enrolment was added.
21/05/2019: Trial’s existence confirmed by NHS Health Research Authority.
