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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
United Arab Emirates University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring Antioxidant, vitamins, Diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 11, 2012
    Last Updated
    September 19, 2012
    Sponsor
    United Arab Emirates University
    Collaborators
    Tawam Hospital
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    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

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

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