Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/04/2008
Date assigned
12/06/2008
Last edited
27/03/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gareth Davison

ORCID ID

Contact details

University of Ulster
Jordanstown
Shore Road
Newtownabbey
BT37 OQB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Molecular detection of exercise-induced free radicals following ascorbate prophylaxis in type one diabetes mellitus: a randomised controlled trial

Acronym

Study hypothesis

Consistent with the human literature, we hypothesise that compared to healthy controls:
1. Exercise would compound basal oxidative stress in type one diabetics, and
2. Ascorbic acid would provide effective prophylaxis

A randomised, double-blind, placebo-controlled experimental design incorporating an electron paramagnetic resonance (EPR) spin-trapping technique combined with a comprehensive assessment of lipid peroxidation and non-enzymatic antioxidants will be employed to test these hypotheses.

Ethics approval

Ethics approval received from The Bro Taf (Wales) Research Ethics Committee on the 18th December 1996 (ref: 96/1649).

Study design

A balanced single-centre randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type one diabetes mellitus

Intervention

Subjects were randomised to receive:
1. 1 g ascorbic acid two hours prior to exercise
2. Placebo two hours prior to exercise

Supplementation took place once only for both treatment groups, and the follow up was conducted immediately post-exercise and 24 hours later via telephone.

Intervention type

Drug

Phase

Not Specified

Drug names

Ascorbic acid

Primary outcome measures

Free radical species in human blood, measured before supplementation, two hours after supplementation (before exercise) and immediately after exercise.

Secondary outcome measures

Blood biochemical markers such as lipid hydroperoxides, vitamin C and vitamin E, measured before supplementation, two hours after supplementation (before exercise) and immediately after exercise.

Overall trial start date

01/01/2001

Overall trial end date

01/06/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Diabetic volunteers were recruited from the adult diabetic clinic at the University Hospital of Wales, based on the following inclusion criteria:
1. Males aged 18 - 30 years
2. Glycosylated haemoglobin (HbA1c) of between 7 - 10%
3. Microalbuminuria negative
4. No underlying vascular complications

Non-diabetic control subjects were recruited from the student population of the University of Glamorgan, based on the following inclusion criteria:
1. Matched for age
2. Matched for fitness
3. No metabolic or circulatory medical condition
4. Had no family history of diabetes as confirmed via interview and medical history questionnaire

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

12 male type one diabetic patients; 14 apparently healthy male volunteers

Participant exclusion criteria

1. Cardiovascular disease
2. Hypertension
3. Any other known cardiac complication

Recruitment start date

01/01/2001

Recruitment end date

01/06/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Ulster
Newtownabbey
BT37 OQB
United Kingdom

Sponsor information

Organisation

University of Glamorgan (UK)

Sponsor details

Pontypridd
Cardiff
CF37 1DL
United Kingdom

Sponsor type

University/education

Website

http://www.glam.ac.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

University of Glamorgan (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University Hospital of Wales (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18769906

Publication citations

  1. Results

    Davison GW, Ashton T, George L, Young IS, McEneny J, Davies B, Jackson SK, Peters JR, Bailey DM, Molecular detection of exercise-induced free radicals following ascorbate prophylaxis in type 1 diabetes mellitus: a randomised controlled trial., Diabetologia, 2008, 51, 11, 2049-2059, doi: 10.1007/s00125-008-1101-1.

Additional files

Editorial Notes