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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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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
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

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
Type2 Diabetes Dietary Supplement: vitamin D Dietary Supplement: vitamin D placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2017
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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




Primary Outcome Measures :
  1. serum Fasting blood suger, [ Time Frame: Change frome baseline at 3 months ]
  2. serum HbA1c [ Time Frame: Change frome baseline at 3 months ]
  3. serum fasting insulin [ Time Frame: Change frome baseline at 3 months ]

Secondary Outcome Measures :
  1. serum YKL40 [ Time Frame: Change frome baseline at 3 months ]
  2. serum AGES [ Time Frame: Change frome baseline at 3 months ]
  3. serum IL6 [ Time Frame: Change frome baseline at 3 months ]
  4. serum TNF-alpha [ Time Frame: Change frome baseline at 3 months ]
  5. serum PAI-1 [ Time Frame: Change frome baseline at 3 months ]
  6. RAGE gene expression [ Time Frame: Change frome baseline at 3 months ]
  7. YKL40 gene expression [ Time Frame: Change frome baseline at 3 months ]
  8. glyoxalase enzyme gene expression [ Time Frame: Change frome baseline at 3 months ]


Information from the National Library of Medicine

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

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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03008057     History of Changes
Other Study ID Numbers: 32615
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: January 2, 2017
Last Verified: December 2016

Keywords provided by Tehran University of Medical Sciences:
vitamin D
YKL40
PAI-1
RAGE
AGEs
glyoxalase enzyme
TNF-alpha
IL-6
Diabetes

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents