Clinical trial NCT03008057: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Type2 Diabetes
Keywords: vitamin D
YKL40
PAI-1
RAGE
AGEs
glyoxalase enzyme
TNF-alpha
IL-6
Diabetes
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 42
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: serum HbA1c
timeFrame: Change frome baseline at 3 months
measure: serum fasting insulin
timeFrame: Change frome baseline at 3 months
measure: serum Fasting blood suger,
timeFrame: Change frome baseline at 3 months
Secondary outcomes:
measure: serum AGES
timeFrame: Change frome baseline at 3 months
measure: serum IL6
timeFrame: Change frome baseline at 3 months
measure: serum TNF-alpha
timeFrame: Change frome baseline at 3 months
measure: serum PAI-1
timeFrame: Change frome baseline at 3 months
measure: RAGE gene expression
timeFrame: Change frome baseline at 3 months
measure: YKL40 gene expression
timeFrame: Change frome baseline at 3 months
measure: glyoxalase enzyme gene expression
timeFrame: Change frome baseline at 3 months
measure: serum IL-17
timeFrame: Change frome baseline at 3 months
measure: Serum IL-4
timeFrame: Change frome baseline at 3 months
measure: serum Transforming growth factor beta
timeFrame: Change frome baseline at 3 months
measure: serum YKL40
timeFrame: Change frome baseline at 3 months
Other outcomes:
Locations:
Study officials:
References:
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.
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.