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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|ClinicalTrials.gov Identifier: NCT03008057|
Recruitment Status : Unknown
Verified December 2016 by Tehran University of Medical Sciences.
Recruitment status was: Enrolling by invitation
First Posted : January 2, 2017
Last Update Posted : January 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type2 Diabetes||Dietary Supplement: vitamin D Dietary Supplement: vitamin D placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Primary Purpose:||Supportive Care|
|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 Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||June 2017|
Active Comparator: vitamin D supplementation
patients with type 2 diabetes receive 1 tablet (4000 IU ) vitamin D supplementation, one time a day, for 3 months.
Dietary Supplement: vitamin D
vitamin D supplement, 4000 IU tablet daily , one time a day, for 3 months
Placebo Comparator: vitamin D placebo
patients with type 2 diabetes receive one tablet of vitamin D placebo for 3 months
Dietary Supplement: vitamin D placebo
vitamin D placebo tablet (Containing starch powder), one time a day, for 3 months
- serum Fasting blood suger, [ Time Frame: Change frome baseline at 3 months ]
- serum HbA1c [ Time Frame: Change frome baseline at 3 months ]
- serum fasting insulin [ Time Frame: Change frome baseline at 3 months ]
- serum YKL40 [ Time Frame: Change frome baseline at 3 months ]
- serum AGES [ Time Frame: Change frome baseline at 3 months ]
- serum IL6 [ Time Frame: Change frome baseline at 3 months ]
- serum TNF-alpha [ Time Frame: Change frome baseline at 3 months ]
- serum PAI-1 [ Time Frame: Change frome baseline at 3 months ]
- RAGE gene expression [ Time Frame: Change frome baseline at 3 months ]
- YKL40 gene expression [ Time Frame: Change frome baseline at 3 months ]
- glyoxalase enzyme gene expression [ Time Frame: Change frome baseline at 3 months ]