Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/04/2019
Date assigned
26/04/2019
Last edited
15/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

https://www.ncl.ac.uk/

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

Publication citations

Additional files

Editorial Notes

15/04/2019: Trial’s existence confirmed by NHS HRA North East Tyne & Wear South Research Ethics Committee.