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The Assessment of the Effect of Vitamin D Supplementation on Inflammatory and Endothelial Factors in the Patients With Type 2 Diabetes .

Primary Purpose

Type2 Diabetes

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
vitamin D
vitamin D placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type2 Diabetes focused on measuring vitamin D, YKL40, PAI-1, RAGE, AGEs, glyoxalase enzyme, TNF-alpha, IL-6, Diabetes

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- diabetic type 2 patients 35-65 years old, body mass index in the range 18.5- 30 ,literate, willingness to participation,avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention -

Exclusion Criteria:

  • people who have used vitamin D supplements in last 3 months, having chronic renal disease , GI disease, Hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, treatment with orlistat or sibutramine for weight loss, pregnancy and lactation, treatment with insulin or Thiazolidinediones, Smokers,sever change in regular diet and life style,change in type and dosage of regular medication (s)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    vitamin D supplementation

    vitamin D placebo

    Arm Description

    patients with type 2 diabetes receive 1 tablet (4000 IU ) vitamin D supplementation, one time a day, for 3 months.

    patients with type 2 diabetes receive one tablet of vitamin D placebo for 3 months

    Outcomes

    Primary Outcome Measures

    serum HbA1c
    serum fasting insulin
    serum Fasting blood suger,

    Secondary Outcome Measures

    serum AGES
    serum IL6
    serum TNF-alpha
    serum PAI-1
    RAGE gene expression
    YKL40 gene expression
    glyoxalase enzyme gene expression
    serum IL-17
    Serum IL-4
    serum Transforming growth factor beta
    serum YKL40

    Full Information

    First Posted
    December 29, 2016
    Last Updated
    July 15, 2021
    Sponsor
    Tehran University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03008057
    Brief Title
    The Assessment of the Effect of Vitamin D Supplementation on Inflammatory and Endothelial Factors in the Patients With Type 2 Diabetes .
    Official Title
    The Assessment of the Effect of Vitamin D Supplementation on the Serum of AGES and Endothelialy Factors and Gene Expression of Glyoxalase Enzyme and YKL-40 Factor in PBMC Cells in the Patients With Type 2 Diabetes .
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    July 2021 (Anticipated)
    Study Completion Date
    July 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tehran University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to determine the effects of vitamin D or placebo for 3 months on the gene expression of glyoxalase enzyme, RAGE, and YKL40 in the peripheral blood mononuclear cell (PBMC) and serum levels of YKL40,AGEs, TNF-α, PAI-1, IL-6, and HbA1c of diabetes type 2 patients.
    Detailed Description
    The aim of this study is to determine the effects of vitamin D or placebo for 3 months on the gene expression of plasma human cartilage glycoprotein 39(YKL40), receptor for advanced glycation end products (RAGE) and glyoxalase enzyme in the peripheral blood mononuclear cell (PBMC) and serum levels of YKL40 ,plasminogen activator inhibitor-1 (PAI-1), TNF-α, advanced glycation end products (AGEs ), IL-6, and HbA1c of diabetes type 2 patients. In this randomized, double-blind clinical trial, placebo-controlled study, 84 women and men with type 2 diabetes are enrolled from the Iranian Center of diabetes. At the start of study, all participants will sign informed consent and complete a general information form. 24-hour food record for 3 days will be taken from the patients at the beginning and the end of the study. Selected samples by using stratified randomization method based on sex, gender and body mass index (BMI) are classified into 2 groups: 1) receiving vitamin D supplement 2) receiving vitamin D placebo bo. The vitamin D supplement group will receive 4000 IU (100 microgram) daily for 3 months. The vitamin D placebo group will also receive placebo containing starch both similar in terms of color, shape and size. participants are advised to maintain their diet, level of physical activity and medication dose during the study. Blood samples will be collected after anthropometric parameter measuring then target biochemical parameters, gene expression and serum levels and physical activity will be measured before and after the trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type2 Diabetes
    Keywords
    vitamin D, YKL40, PAI-1, RAGE, AGEs, glyoxalase enzyme, TNF-alpha, IL-6, Diabetes

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    vitamin D supplementation
    Arm Type
    Active Comparator
    Arm Description
    patients with type 2 diabetes receive 1 tablet (4000 IU ) vitamin D supplementation, one time a day, for 3 months.
    Arm Title
    vitamin D placebo
    Arm Type
    Placebo Comparator
    Arm Description
    patients with type 2 diabetes receive one tablet of vitamin D placebo for 3 months
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    vitamin D
    Intervention Description
    vitamin D supplement, 4000 IU tablet daily , one time a day, for 3 months
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    vitamin D placebo
    Intervention Description
    vitamin D placebo tablet (Containing starch powder), one time a day, for 3 months
    Primary Outcome Measure Information:
    Title
    serum HbA1c
    Time Frame
    Change frome baseline at 3 months
    Title
    serum fasting insulin
    Time Frame
    Change frome baseline at 3 months
    Title
    serum Fasting blood suger,
    Time Frame
    Change frome baseline at 3 months
    Secondary Outcome Measure Information:
    Title
    serum AGES
    Time Frame
    Change frome baseline at 3 months
    Title
    serum IL6
    Time Frame
    Change frome baseline at 3 months
    Title
    serum TNF-alpha
    Time Frame
    Change frome baseline at 3 months
    Title
    serum PAI-1
    Time Frame
    Change frome baseline at 3 months
    Title
    RAGE gene expression
    Time Frame
    Change frome baseline at 3 months
    Title
    YKL40 gene expression
    Time Frame
    Change frome baseline at 3 months
    Title
    glyoxalase enzyme gene expression
    Time Frame
    Change frome baseline at 3 months
    Title
    serum IL-17
    Time Frame
    Change frome baseline at 3 months
    Title
    Serum IL-4
    Time Frame
    Change frome baseline at 3 months
    Title
    serum Transforming growth factor beta
    Time Frame
    Change frome baseline at 3 months
    Title
    serum YKL40
    Time Frame
    Change frome baseline at 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - diabetic type 2 patients 35-65 years old, body mass index in the range 18.5- 30 ,literate, willingness to participation,avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention - Exclusion Criteria: people who have used vitamin D supplements in last 3 months, having chronic renal disease , GI disease, Hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, treatment with orlistat or sibutramine for weight loss, pregnancy and lactation, treatment with insulin or Thiazolidinediones, Smokers,sever change in regular diet and life style,change in type and dosage of regular medication (s)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31673295
    Citation
    Omidian M, Djalali M, Javanbakht MH, Eshraghian MR, Abshirini M, Omidian P, Alvandi E, Mahmoudi M. Effects of vitamin D supplementation on advanced glycation end products signaling pathway in T2DM patients: a randomized, placebo-controlled, double blind clinical trial. Diabetol Metab Syndr. 2019 Oct 26;11:86. doi: 10.1186/s13098-019-0479-x. eCollection 2019.
    Results Reference
    derived
    PubMed Identifier
    31405646
    Citation
    Omidian M, Mahmoudi M, Abshirini M, Eshraghian MR, Javanbakht MH, Zarei M, Hasani H, Djalali M. Effects of vitamin D supplementation on depressive symptoms in type 2 diabetes mellitus patients: Randomized placebo-controlled double-blind clinical trial. Diabetes Metab Syndr. 2019 Jul-Aug;13(4):2375-2380. doi: 10.1016/j.dsx.2019.06.011. Epub 2019 Jun 11.
    Results Reference
    derived

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    The Assessment of the Effect of Vitamin D Supplementation on Inflammatory and Endothelial Factors in the Patients With Type 2 Diabetes .

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