|
ISRCTN
|
ISRCTN96164937
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Exercise and vitamin C supplementation in type one diabetes mellitus
|
|
Scientific title
|
Molecular detection of exercise-induced free radicals following ascorbate prophylaxis in type one diabetes mellitus: a randomised controlled trial
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
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
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Type one diabetes mellitus
|
|
Participants - 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
|
|
Participants - exclusion criteria
|
1. Cardiovascular disease
2. Hypertension
3. Any other known cardiac complication
|
|
Anticipated start date
|
01/01/2001
|
|
Anticipated end date
|
01/06/2001
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
12 male type one diabetic patients; 14 apparently healthy male volunteers
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Free radical species in human blood, measured before supplementation, two hours after supplementation (before exercise) and immediately after exercise.
|
|
Secondary outcome measure(s)
|
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.
|
|
Sources of funding
|
1. University of Glamorgan (UK)
2. University Hospital of Wales (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Gareth
Davison
|
|
Address
|
University of Ulster
Jordanstown
Shore Road
|
|
City/town
|
Newtownabbey
|
|
Zip/Postcode
|
BT37 OQB
|
|
Country
|
United Kingdom
|
|
Sponsor
|
University of Glamorgan (UK)
|
|
Address
|
Pontypridd
|
|
City/town
|
Cardiff
|
|
Zip/Postcode
|
CF37 1DL
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www.glam.ac.uk/
|
|
Date applied
|
16/04/2008
|
|
Last edited
|
12/06/2008
|
|
Date ISRCTN assigned
|
12/06/2008
|
