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
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
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
NCT ID
NCT03008057
First Posted
December 29, 2016
Last Updated
July 15, 2021
Sponsor
Tehran University of Medical Sciences
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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