Effects of Antioxidants and B Vitamins Supplements on Inflammation in Obese Diabetic Patients
Primary Purpose
Diabetes, Obesity
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
vitamins
Placebo
Sponsored by

About this trial
This is an interventional prevention trial for Diabetes focused on measuring Antioxidant, vitamins, Diet
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
vitamins pills
pills
Arm Description
antioxidant and B vitamins vitamins vitamin --------------------------------------------------------------------------------
MICROCRYSTALLINE CELLULOSE
Outcomes
Primary Outcome Measures
Inflammation
Oxidative damage
Secondary Outcome Measures
Antioxidant status
Full Information
NCT ID
NCT01691365
First Posted
September 11, 2012
Last Updated
September 19, 2012
Sponsor
United Arab Emirates University
Collaborators
Tawam Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01691365
Brief Title
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
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United Arab Emirates University
Collaborators
Tawam Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Obesity
Keywords
Antioxidant, vitamins, Diet
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitamins pills
Arm Type
Active Comparator
Arm Description
antioxidant and B vitamins vitamins vitamin
--------------------------------------------------------------------------------
Arm Title
pills
Arm Type
Placebo Comparator
Arm Description
MICROCRYSTALLINE CELLULOSE
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamins
Other Intervention Name(s)
Antioxidants, B vitamins
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Capsule shell (Hydroxypropylmethyl cellulose, Hydroxypropylcellulose, Propylene glycol as stabilizer, Colour-Titanium dioxide)
Primary Outcome Measure Information:
Title
Inflammation
Time Frame
3 months
Title
Oxidative damage
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Antioxidant status
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Infections
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salah Gariballa, MD
Organizational Affiliation
United Arab Emirates University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
31159801
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.
Results Reference
derived
Learn more about this trial
Effects of Antioxidants and B Vitamins Supplements on Inflammation in Obese Diabetic Patients
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