Exercise and vitamin C supplementation in type one diabetes mellitus
| ISRCTN | ISRCTN96164937 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96164937 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/04/2008
- Registration date
- 12/06/2008
- Last edited
- 27/03/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gareth Davison
Scientific
Scientific
University of Ulster
Jordanstown
Shore Road
Newtownabbey
BT37 OQB
United Kingdom
Study information
| Study design | A balanced single-centre randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Molecular detection of exercise-induced free radicals following ascorbate prophylaxis in type one diabetes mellitus: a randomised controlled trial |
| Study objectives | 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(s) | Ethics approval received from The Bro Taf (Wales) Research Ethics Committee on the 18th December 1996 (ref: 96/1649). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ascorbic acid |
| Primary outcome measure | 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 study start date | 01/01/2001 |
| Completion date | 01/06/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 12 male type one diabetic patients; 14 apparently healthy male volunteers |
| Key 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 |
| Key exclusion criteria | 1. Cardiovascular disease 2. Hypertension 3. Any other known cardiac complication |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 01/06/2001 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
University of Ulster
Newtownabbey
BT37 OQB
United Kingdom
BT37 OQB
United Kingdom
Sponsor information
University of Glamorgan (UK)
University/education
University/education
Pontypridd
Cardiff
CF37 1DL
Wales
United Kingdom
| Website | http://www.glam.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/02mzn7s88 |
Funders
Funder type
Hospital/treatment centre
University of Glamorgan (UK)
No information available
University Hospital of Wales (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2008 | Yes | No |
