Plain English Summary
Background and study aims
Generation of harmful free radicals – oxidative stress - in the wake of poor glucose control is a key link between diabetes and many of the cardiovascular (heart and circulation) conditions that cause much of the health issues that occur in this patient group. In particular, oxidative stress is a critical player in large vessel disease that leads to myocardial infarction (heart attack), stroke and peripheral vascular disease (a condition where fatty deposits have built up in blood vessels and restricts the blood supply) on account of damage to the protective lining of arteries. Oxidative stress also alters molecules that carry fats in the blood and is associated with increased stickiness between platelets and white blood cells. Research has demonstrated that insulin pump therapy in people with type 2 diabetes is associated with reduced markers of oxidative stress as well as less excursion (i.e. rapid change) in blood glucose levels, however, in the UK pump therapy is reserved for people with type 1 diabetes and oxidative stress markers have not been explored in this group. Moreover, newer techniques are available to measure oxidative stress and platelet-white cell adhesion has not been examined in any group of people on pump therapy. We aim to compare markers of oxidative stress and platelet-white cell adhesion in people with type 1 diabetes using insulin pump therapy compared with those on multiple daily insulin injections. As the previous research suggested that oxidative stress was lower in people using statin therapy to reduce cholesterol the groups will be further equally subdivided into those receiving statin therapy compared with those who are not.
Who can participate?
Adults aged 18-60 with type 1 diabetes that have their condition managed either by insulin pump therapy (CSII) or multiple daily insulin injections.
What does the study involve?
Participants attend go to the study clinic on one occasion to provide a fasting sample urine sample (to check oxidative stress markers) and also blood sample to measure platelet-white cell adhesion and lipid levels along with measurement of diabetes control. Height, weight and blood pressure for each participant is also recorded.
What are the possible benefits and risks of participating?
No direct patient benefits and no risks as only providing a urine and blood sample on one occasion.
Where is the study run from?
Highland Diabetes Institute, University of the Highlands and Islands (UK)
When is the study starting and how long is it expected to run for?
November 2014 to December 2015
Who is funding the study?
NHS Highland Research & Development Endowment Fund (UK)
Who is the main contact?
Professor Sandra MacRury
Trial website
Contact information
Type
Public
Primary contact
Prof Sandra MacRury
ORCID ID
http://orcid.org/0000-0001-7599-1302
Contact details
Division of Health Research
University of the Highlands and Islands
Centre for Health Science
Inverness
IV2 3JH
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
602SM
Study information
Scientific title
A pilot study to investigate whether patients with type 1 diabetes receiving insulin pump therapy have reduced markers of oxidative stress and cardiovascular risk compared to those on multiple daily injections
Acronym
Study hypothesis
We postulate that patients with type 1 diabetes managed by insulin pump therapy (CSII) and receiving statin therapy will have lower levels of oxidative stress, endothelial dysfunction and platelet-monocyte conjugation than those on CSII not on statin therapy or those on MDI insulin therapy with or without statin therapy
Ethics approval
North of Scotland Research Ethics Committee, 25/04/2014, ref: 14/NS/0054
Study design
Single-centre pilot comparative clinical study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Type 1 diabetes
Intervention
The study population will be drawn from the diabetes population attending the diabetes clinic at Raigmore Hospital in Inverness. Forty eight people with type 1 diabetes > 5 years will be recruited. 50% of these participants (12 on pump therapy and 12 not on pump therapy) should be receiving statin therapy for a minimum of 6 months duration.
Patients will attend for a single visit having fasted from 10 pm the previous evening and at which a venous blood sample will be drawn. Patients will provide a urine sample from the first void on the visit day. Height, weight and blood pressure will be assessed at the visit
Intervention type
Mixed
Phase
Drug names
Primary outcome measures
To determine if insulin pump therapy reduces oxidative stress, endothelial dysfunction and platelet-monocyte conjugation in patients with type 1 diabetes
Secondary outcome measures
To determine if insulin pump therapy + statins have a synergistic effect in terms of reducing oxidative stress, endothelial dysfunction and platelet-monocyte conjugation in patients with type 1 diabetes
Overall trial start date
01/11/2014
Overall trial end date
31/12/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with type 1 diabetes
2. Group A: patients not on insulin pump therapy and not on statin n=12
3. Group B: patients not on insulin pump therapy, but on statin n=12
4. Group C: patients on insulin pump therapy > 6 months and not on a statin n=12
5. Group D: patients on insulin pump therapy > 6 months and on a statin n=12
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48
Participant exclusion criteria
1. Type 2 diabetes
2. Very poor glucose control (HbA1c > 84 mmol/mol (10%)
3. Renal impairment (eGFR < 60ml/min/kg)
4. Recently diagnosed patients (<5 years)
5. Smokers or recently stopped (<6 months) ex-smokers
6. Chronic inflammatory disease (e.g. rheumatoid arthritis, Inflammatory bowel disease, asthma, chronic obstructive pulmonary disease)
Recruitment start date
01/11/2014
Recruitment end date
31/12/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Highland Diabetes Institute, University of the Highlands and Islands
Inverness
IV2 3JH
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
NHS Highland Research & Development Endowment Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Scottish Society of Physicians
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary