The blood vessel protecting cell response to exercise in people with and without type 1 diabetes
| ISRCTN | ISRCTN63739203 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63739203 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | V3 14/07/16 |
| Sponsor | Newcastle University |
| Funders | Diabetes Research and Wellness Foundation, Faculty of Medical Sciences, Newcastle University |
- Submission date
- 20/08/2019
- Registration date
- 23/08/2019
- Last edited
- 18/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Exercise mobilises endothelial progenitor cells (EPCs), a cell that circulates within the blood and plays a role in the repair and formation of new blood vessels in healthy individuals. Higher numbers of these cells are associated with better blood vessel function and reduced heart disease and are released into the circulation during and after exercise. While it is known that individuals with type 1 diabetes, older individuals and individuals with lower fitness levels have a reduced number of circulating EPCs at rest, it is not known what the response to exercise is in individuals with type 1 diabetes and to what extent clinical factors such as age, fitness level and inflammation influences the number of EPCs. This study will explore how numbers of EPCs at rest and after exercise differ between T1D and healthy participants, and will explore clinical factors that predict the numbers.
Who can participate?
Patients aged 18-65 with type 1 diabetes and age, sex and fitness-matched healthy volunteers
What does the study involve?
Participants with type 1 diabetes undergo a urine test and a mixed meal tolerance test. Both type 1 diabetes and healthy control participants undergo a graded exercise test before a fixed bout of moderate-intensity walking exercise for 45 minutes, with blood samples taken before, immediately after and 1 hour after the exercise to measure the numbers of EPCs in their blood.
What are the possible benefits and risks of participating?
Participants will find out about their individual responses to exercise, receive feedback on fitness, and contribute to the care and management of those with type 1 diabetes. The risks of taking part include experiencing low blood sugar, injury and muscle soreness.
Where is the study run from?
The study is being run by Newcastle University and takes place in the clinical research facility in the Royal Victoria Infirmary (UK)
When is the study starting and how long is it expected to run for?
October 2016 to September 2019
Who is funding the study?
1. Diabetes Research and Wellness Foundation (UK)
2. Newcastle University (UK)
Who is the main contact?
1. Dr Daniel West
Daniel.West@newcastle.ac.uk
2. Guy Taylor
G.Taylor3@newcastle.ac.uk
Contact information
Public
Institute of Cellular Medicine
Newcastle University
Newcastle Upon Tyne
NE2 4HH
United Kingdom
 ORCID ID |
0000-0003-2246-4925 |
|---|---|
| Phone | +44 (0)191 208 7076 |
| daniel.west@ncl.ac.uk |
Public
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 | +44 (0)1912088264 |
| g.taylor3@newcastle.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Acute observational trial |
| Secondary study design | Comparison |
| Study type | Participant information sheet |
| Scientific title | Endothelial progenitor cell (EPCs) response to exercise in individuals with and without type 1 diabetes |
| Study objectives | Individuals with type 1 diabetes will have reduced numbers of EPCs and progenitor cells. Type 1 diabetes participants with higher residual beta-cell function, shorter duration of diabetes, younger age and better control will have increased numbers of these cells. |
| Ethics approval(s) | 1. Approved 02/09/2016, North East Tyne & Wear South Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Dr, Newcastle upon Tyne, NE2 4NQ; Tel: +44 (0)207 104 8026; Email: nrescommittee.northeast-tyneandwearsouth@nhs.net), ref: 16/NE/0192 2. Approved 04/06/2018, Faculty of Medical Science Ethics Committee (Research & Innovation office, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, NE2 4HH; Tel: +44 (0)191 208 5301; Email: fmsethics@ncl.ac.uk), ref: 1516/5648/2018 |
| Health condition(s) or problem(s) studied | Type 1 diabetes |
| Intervention | 30 patients with Type 1 diabetes with a wide range of ages, duration of diabetes, fitness, glycaemic control and residual beta-cell function will be recruited. Healthy controls who are age, gender and fitness matched will also be recruited. Type 1 diabetes participants will be identified using urinary C-peptide to Creatinine Ratio testing, and those eligible will complete a mixed meal tolerance test to establish maximal stimulated serum C-peptide concentrations. Both type 1 diabetes and healthy control participants will complete a graded exercise test to determine VO2peak before completing a fixed bout of moderate-intensity walking exercise at 60% VO2 peak for 45 minutes, with blood samples taken before, immediately after and 1 hour after the exercise. |
| Intervention type | Other |
| Primary outcome measure(s) |
Number of EPCs (CD34+, CD45dim, VEGFR2 and CD34+, CD45dim, CD31+) measured by flow cytometry pre, immediately post and 1-hour post the exercise test between type 1 diabetes and healthy controls |
| Key secondary outcome measure(s) |
1. Clinical factors at baseline: |
| Completion date | 30/09/2019 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | T1D: 1. Aged 18-65 years old 2. Diagnosed with T1D 3. Treated with exogenous insulin (pump or injection) 4. Free from diabetes complications Healthy: 1. Aged 18-65 years old 2. Free from any chronic diseases |
| Key exclusion criteria | Cardiovascular disease or detection via ECG screening |
| Date of first enrolment | 01/11/2016 |
| Date of final enrolment | 01/07/2019 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Newcastle upon Tyne
NE3 3HD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 | 15/07/2021 | 19/07/2021 | Yes | No | |
| Results article | 11/02/2022 | 06/09/2023 | Yes | No | |
| Results article | 25/04/2024 | 18/09/2024 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/09/2024: Publication reference added.
06/09/2023: Publication reference added.
19/07/2021: Publication reference added.
05/10/2020: The intention to publish date was changed from 01/05/2020 to 01/01/2021.
30/12/2019: Internal review.
11/12/2019: Internal review.
10/12/2019: Internal review.
22/08/2019: Trial's existence confirmed by ethics committee.
