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

Phase 4

Completed

• Conditions: Diabetes; Obesity
• Interventions: Dietary Supplement: vitamins; Drug: Placebo

• Registration Number: NCT01691365
• Lead Sponsor: United Arab Emirates University

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.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-12
• Study Completion: 2011-06
• Status Verified: 2012-09
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-19
• Last Update Submitted: 2012-09-19
• Study First Posted: 2012-09-24
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vitamins pills	vitamins	antioxidant and B vitamins vitamins vitamin --------------------------------------------------------------------------------
pills	Placebo	MICROCRYSTALLINE CELLULOSE

Primary Outcome Measures

Name	Time	Method
Inflammation	3 months
Oxidative damage	3 months

Secondary Outcome Measures

Name	Time	Method
Antioxidant status	3 months