the Effect of Vitamin D on the Serum Thioredoxin, TBP-2, Thioredoxin Reductase, Gene Expression of TBP-2 in Patients With Type II Diabetes

Study Overview
=================
Brief Summary
-----------------
The aim of this study is the comparision between the effects of vitamin D or placebo supplementation for 2 months in serum level of thioredoxin, TBP-2 and thioredoxin reductase activity in patients with type 2 diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: vitamin D
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: literate, willingness to participation, diabetic patients 30- 60 years old, body mass index in the range 18.5- 35, 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 -

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: diabetes, vitamin D<br>patients with type 2 diabetes who receive 4000 IU/day vitamin D | Dietary Supplement: vitamin D<br>* one tab 4000 IU/day vitamin D<br>|
| Placebo Comparator: placebo, diabetes<br>patients with type 2 diabetes who receive one tab placebo | Dietary Supplement: placebo<br>* one tab per day placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum total cholesterol |  | change from baseline at 2 months | 
| serum HDL cholesterol |  | change from baseline at 2 months | 
| serum triglycerides level |  | change from baseline at 2 months | 
| fasting plasma glucose |  | change from baseline at 2 months | 
| serum LDL cholesterol |  | change from baseline at 2 months | 
| complete blood count (CBC) |  | change from baseline at 2 months | 
| HbA1c |  | change from baseline at 2 months | 
| serum insulin |  | change from baseline at 2 months | 
| serum calcidiol |  | change from baseline at 2 months | 
| thioredoxin |  | change from baseline at 2 months | 
| thioredoxin binding protein 2 (TBP-2) |  | change from baseline at 2 months | 
| erytrocyte thioredoxin reductase |  | change from baseline at 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GENE EXPRESSION OF TBP-2 |  | change from baseline at 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thioredoxin, TBP-2, thioredoxin reductase, vitamin D, DIABETES