Diabetes, Obesity
Conditions
Keywords
Antioxidant, vitamins, Diet
Brief summary
Substantial evidence shows that diets incorporating antioxidants and B-group vitamins can offer significant protection against infections and cardiovascular disease (CVD) especially in diabetic patients. The proposed study will determine whether improvements in antioxidants and B-group vitamins in diabetic patients who are known to have a high risk of CVD will lead to a clinical benefit
Detailed description
Following informed written consent 96 diabetic patients will be randomly assigned to receive either an oral dose of daily B-group vitamins (5 mg folic acid, 5mg vitamin B-2, 50 mg vitamin B-6, 0.4 mg vitamin B-12) and antioxidant vitamins \[800 IU (727mg) of a-tocopherol and 500mg of vitamin C\] \[n=48\], or no supplements \[n= 48\] daily for 90 days. All subjects will have three assessments, at baseline, 3, and 12 months post-randomisation. The assessment will include markers of inflammation, endothelial dysfunction, oxidative stress, antioxidants, total plasma homocysteine and risk of infections. A fasting 15-ml of blood will be taken for measurements of total plasma homocysteine concentration, markers of inflammation, endothelial dysfunction, oxidative damage and vitamin concentrations. Further information on clinical variables which may influence endothelial dysfunction, antioxidant capacity, immunity and diabetes control status will be collected and adjusted for during analysis. Potential Significance- the study will help to clarify the temporal relationships between , markers of inflammation, endothelial dysfunction and oxidative stress and risk of infections and form the basis of appropriate intervention strategies to minimise the long-term complications associated with type 2 diabetes mellitus.
Interventions
Placebo Capsule shell (Hydroxypropylmethyl cellulose, Hydroxypropylcellulose, Propylene glycol as stabilizer, Colour-Titanium dioxide)
a capsule of antioxidant vitamins 221mg of alpha tocopherol and 167mg of vitamin C and B-group vitamins (1.67 mg folic acid, 1.67mg vitamin B-2, 20 mg vitamin B-6, 0.134 mg vitamin B-12) or an identical placebo daily for 90 days
Sponsors
Study design
Eligibility
Inclusion criteria
* Type 2 Diabetes mellitus
Exclusion criteria
* severe chronic clinical or psychiatric disease, * participating in other intervention trials, * on dietary supplements and * those unable to give an informed written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inflammation | 3 months |
| Oxidative damage | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Antioxidant status | 3 months |
Other
| Measure | Time frame |
|---|---|
| Infections | 12 months |