Clinical trial NCT01691365: Effects of Antioxidants and B Vitamins Supplements on Inflammation in Obese Diabetic Patients
Official title: Oxidative Damage and Inflammation in Obese Diabetic Emirati Subjects Supplemented With Antioxidants and B-vitamins: a Randomized Placebo-controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Obesity
Keywords: Antioxidant
vitamins
Diet
Lead sponsor: United Arab Emirates University
Sponsor class: OTHER
Collaborators: name: Tawam Hospital
First posted: 2012-09-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inflammation
timeFrame: 3 months
measure: Oxidative damage
timeFrame: 3 months
Secondary outcomes:
measure: Antioxidant status
timeFrame: 3 months
Other outcomes:
measure: Infections
timeFrame: 12 months
Locations:
Study officials:
affiliation: United Arab Emirates University
name: Salah Gariballa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gariballa S, Alkaabi J, Yasin J, Al Essa A. Total adiponectin in overweight and obese subjects and its response to visceral fat loss. BMC Endocr Disord. 2019 Jun 3;19(1):55. doi: 10.1186/s12902-019-0386-z.