How does exercise impact bone turnover in people with and without Type 1 diabetes?

ISRCTN ISRCTN10346879
DOI https://doi.org/10.1186/ISRCTN10346879
IRAS number 201939
Secondary identifying numbers IRAS ID: 201939
Submission date
15/04/2019
Registration date
26/04/2019
Last edited
03/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Daniel West
Public

Institute of Cellular Medicine
Room M4.077, William Leech Building
Newcastle University
Newcastle upon Tyne
NE2 4HH
Newcastle upon Tyne
NE2 4HH
United Kingdom

ORCiD logoORCID ID 0000-0003-2246-4925
Phone 0191 2087076
Email daniel.west@newcastle.ac.uk

Study information

Study designObservational case-control study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleThe bone metabolic response to exercise in people with and without Type 1 diabetes: an observational study
Study objectivesType 1 diabetes patients demonstrate altered bone metabolism responses in response to exercise
Ethics approval(s)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
Health condition(s) or problem(s) studiedType 1 diabetes
InterventionPatients 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 typeBehavioural
Primary outcome measureChanges 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 measuresChanges in ionised calcium, phospohate, calcium, albumin from rest, to immediately after exercise. These will be measured by routine biochemical assay.
Overall study start date01/06/2015
Completion date01/10/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants30 (15 type 1 diabetes, 15 control)
Total final enrolment30
Key inclusion criteria1. Aged 18-65 years old
2. Clinically diagnosed Type 1 diabetes
3. Treated with exogenous insulin (pump or injection)
4. Free from diabetes complications
Key exclusion criteria1. Type 1 diabetes participants duration of disease less than 1 year
2. Type 1 diabetes HbA1c >10%
3. Musculoskeletal injury
Date of first enrolment01/10/2016
Date of final enrolment01/07/2019

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Newcastle University
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
Email kay.howes@ncl.ac.uk
Website https://www.ncl.ac.uk/
ROR logo "ROR" https://ror.org/01kj2bm70

Funders

Funder type

University/education

Newcastle University
Private sector organisation / Universities (academic only)
Location
United Kingdom

Results and Publications

Intention to publish date01/04/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe 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 04/11/2020 03/09/2021 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

03/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
15/04/2019: Trial’s existence confirmed by NHS HRA North East Tyne & Wear South Research Ethics Committee.