Plain English Summary
Background and study aims
Diabetes is a condition that causes a person’s blood sugar level to become too high. Insulin is the hormone made by beta-cells in the pancreas and controls the amount of glucose in the blood. There are two main types of diabetes: Type 1 where the pancreas does not produce any insulin and type 2 where the pancreas does not produce enough insulin or the person’s cells do not react to insulin. High blood glucose levels can damage the small blood vessels of the body, and an often underappreciated region are the small vessels that supply the bone. Diabetes is associated with an increased risk of fracture and worsening of bone health, however, there is little information on those with long duration Type 1 diabetes. As exercise is recommended to people with Type 1 diabetes, and exercise can impact bone health, it is important to understand how exercise influences bone metabolism in those with Type 1 diabetes. This study aims to examine how exercise impacts on bone health markers in people with long duration Type 1 diabetes.
Who can participate?
Participants will be recruited from the North East region of England. Participants will be free from muscle / skeletal injury, have no contraindications to exercise, and aged between 18-65. Those with Type 1 diabetes will have an HbA1c <10%, and be treated with exogenous insulin only.
What does the study involve?
After a resting and exercising exercise stress test to quantify maximum heart rate and peak oxygen uptake, participants will attend the Newcastle NIHR Clinical Research Facility (Royal Victoria Infirmary; Leazes Wing) at ~8 am. Participants are required to fast for 12 hours before this. A cannula will be placed in the vein of the participants non-dominant arm and resting blood samples will be collected. The Type 1 diabetes participants’ glucose concentrations will be managed according to current international guidelines.
After 1 hour, participants will conduct 45 minutes of steady state walking exercise at a moderate intensity. Blood samples will be drawn periodically before and after the exercise test. At 1 hour after exercise, the participants will be fed and allowed to return home. Blood samples will be processed for various markers of bone metabolism.
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 and musculoskeletal injury.
Where is the study run from?
Newcastle NIHR Clinical Research Facility (Royal Victoria Infirmary; Leazes Wing), UK
When is the study starting and how long is it expected to run for?
October 2016 to July 2019
Who is funding the study?
The study is funded by the research fellowship from Newcastle University to the chief investigator, Dr Daniel West
Who is the main contact?
Dr Daniel West, daniel.west@newcastle.ac.uk
Trial website
Contact information
Type
Public
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
Newcastle upon Tyne
NE2 4HH
United Kingdom
0191 2087076
daniel.west@newcastle.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IRAS ID: 201939
Study information
Scientific title
The bone metabolic response to exercise in people with and without Type 1 diabetes: an observational study
Acronym
Study hypothesis
Type 1 diabetes patients demonstrate altered bone metabolism responses in response to exercise
Ethics approval
1. Approved 20/02/2016 Newcastle University Faculty of Medical Sciences Ethics Committee (Framlington Place, Newcastle upon Tyne, NE2 4HH; 0191 2086000; res.policy@ncl.ac.uk), ref:1516/6548/2018
2. Approved 15/07/2016 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
Observational case-control study
Primary study design
Observational
Secondary study design
Case-control study
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 and a control group of age, fitness, BMI, gender balanced, non-diabetes controls will be recruited.
Participants will complete a fixed bout of moderate intensity walking exercise at 60% VO2 peak for 45 minutes, with blood samples collected before and after exercise and assessed for markers of bone metabolism.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Changes in CTX, procollagen type 1 N-Terminal propeptide, and parathyroid hormone from rest, to immediately after exercise. These will be measured by routine biochemical assay.
Secondary outcome measures
Changes in ionised calcium, phospohate, calcium, albumin from rest, to immediately after exercise. These will be measured by routine biochemical assay.
Overall trial start date
01/06/2015
Overall trial end date
01/10/2019
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 (15 type 1 diabetes, 15 control)
Participant exclusion criteria
1. Type 1 diabetes participants duration of disease less than 1 year
2. Type 1 diabetes HbA1c >10%
3. Musculoskeletal injury
Recruitment start date
01/10/2016
Recruitment end date
01/07/2019
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
University/education
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
01/04/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list