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
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
-
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.