Effects of Antioxidants and B Vitamins Supplements on Inflammation in Obese Diabetic Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oxidative Damage and Inflammation in Obese Diabetic Emirati Subjects Supplemented With Antioxidants and B-vitamins: a Randomized Placebo-controlled Trail

Conditions
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Diabetes, Obesity

Intervention / Treatment
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* Dietary Supplement: vitamins
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vitamins pills<br>antioxidant and B vitamins vitamins vitamin -------------------------------------------------------------------------------- | Dietary Supplement: vitamins<br>* 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<br>* Other names: B vitamins;|
| Placebo Comparator: pills<br>MICROCRYSTALLINE CELLULOSE | Drug: Placebo<br>* Placebo Capsule shell (Hydroxypropylmethyl cellulose, Hydroxypropylcellulose, Propylene glycol as stabilizer, Colour-Titanium dioxide)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation |  | 3 months | 
| Oxidative damage |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antioxidant status |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antioxidant, vitamins, Diet