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

Type2 Diabetes Clinical Trial

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 .

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03008057
• Other study ID #: 32615
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• Start date: January 2017
• Est. completion date: July 2021

Study information

• Verified date: July 2021
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 42
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Dietary Supplement:
• vitamin D
vitamin D supplement, 4000 IU tablet daily , one time a day, for 3 months
• vitamin D placebo
vitamin D placebo tablet (Containing starch powder), one time a day, for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum HbA1c		Change frome baseline at 3 months
Primary	serum fasting insulin		Change frome baseline at 3 months
Primary	serum Fasting blood suger,		Change frome baseline at 3 months
Secondary	serum AGES		Change frome baseline at 3 months
Secondary	serum IL6		Change frome baseline at 3 months
Secondary	serum TNF-alpha		Change frome baseline at 3 months
Secondary	serum PAI-1		Change frome baseline at 3 months
Secondary	RAGE gene expression		Change frome baseline at 3 months
Secondary	YKL40 gene expression		Change frome baseline at 3 months
Secondary	glyoxalase enzyme gene expression		Change frome baseline at 3 months
Secondary	serum IL-17		Change frome baseline at 3 months
Secondary	Serum IL-4		Change frome baseline at 3 months
Secondary	serum Transforming growth factor beta		Change frome baseline at 3 months
Secondary	serum YKL40		Change frome baseline at 3 months