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

Sponsor
Tehran University of Medical Sciences (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03008057
Collaborator
(none)
42
2
53.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: vitamin D
  • Dietary Supplement: vitamin D placebo
Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
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 :
Jan 1, 2017
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Jul 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. serum HbA1c [Change frome baseline at 3 months]

  2. serum fasting insulin [Change frome baseline at 3 months]

  3. serum Fasting blood suger, [Change frome baseline at 3 months]

Secondary Outcome Measures

  1. serum AGES [Change frome baseline at 3 months]

  2. serum IL6 [Change frome baseline at 3 months]

  3. serum TNF-alpha [Change frome baseline at 3 months]

  4. serum PAI-1 [Change frome baseline at 3 months]

  5. RAGE gene expression [Change frome baseline at 3 months]

  6. YKL40 gene expression [Change frome baseline at 3 months]

  7. glyoxalase enzyme gene expression [Change frome baseline at 3 months]

  8. serum IL-17 [Change frome baseline at 3 months]

  9. Serum IL-4 [Change frome baseline at 3 months]

  10. serum Transforming growth factor beta [Change frome baseline at 3 months]

  11. serum YKL40 [Change frome baseline at 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tehran University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT03008057
Other Study ID Numbers:
  • 32615
First Posted:
Jan 2, 2017
Last Update Posted:
Jul 22, 2021
Last Verified:
Jul 1, 2021
Keywords provided by Tehran University of Medical Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2021