Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/06/2015
Date assigned
09/09/2015
Last edited
13/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

31/12/2015

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

Sponsor information

Organisation

University of the Highlands and Islands (UK)

Sponsor details

Executive Office
Ness Walk
Inverness
IV3 5SQ
United Kingdom

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes