Effects of Vitamin D Supplementation on SOD,IL-6 and Insulin Resistance in Type 2 Diabetes Mellitus (DM)

Study Overview
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Brief Summary
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The aim of this intervention clinical study are: evaluation the effect of vitamin D supplementation on anti-oxidant status, inflammation, insulin resistance in patients type 2 diabetes mellitus. The research question is how the effect of vitamin D supplementation for 3 and 6 months on anti-oxidant status, inflammation and insulin resistance in patients type 2 diabetes mellitus. The main tasks participants will be asked to do: interviews, filling the questionnaires, and giving informed consent after receiving an explanation by the researcher about the purpose of the research taking blood for screening examination which includes examination of Serum Glutamic Pyruvic Transaminase (SGPT), albumin, creatinine and blood Ca. participant who meet the inclusion and exclusion criteria, performed a physical examination (height and weight) and blood collection for examination 25(OH)D. Subjects/participant with vitamin D deficiency and insufficiency will be included in randomization, two groups: the group that received vitamin D3 5,000 IU and the group that received a placebo. Vitamin D 5000 IU and placebo taken daily for 6 months. Observations for 3 months and 6 months from the first time supplementation was given. Treatments they'll be given: During the study, the subject's clinical condition will be monitored. Subject observations are monitored by telephone or google form to subject or their families

Detailed Description
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Participant register: Patients type 2 DM aged > 18 years who went to the Community Health Centers Mampang were interviewed, filled out questionnaires, and gave informed consent.Interview by interviewers with at least high school education after being given training first by researchers. The data is entered in a computer excel table by the researcher. Accuracy, completeness of registration data using the screening form. Data that contains detailed descriptions of each variable used by the registry: Gender: differences in the nature, form, and biological function of men and women that determine differences in reproduction, by interview using a questionnaire and identity card. Duration DM: time from the first time being diagnosed DM until the start of the study, expressed in months Subject's age: calculated from the time the study began with the date of birth listed on the identity card. Standard Operating Procedures to address registry operations and analysis activities: patient recruitment : Patients type 2 DM aged > 18 years who went to the Community Health Centers Mampang were interviewed. data collection: using screening form data management : using table excel computer data analysis : using Statistical Package for the Social Sciences (SPSS) versi 23 report for adverse event: using form adverse event Sample size assessment : formula for hypothesis testing the mean difference of two groups Plan for missing data : back up data Statistical analysis plan to address the primary and secondary objectives: normality test (kolmogorov Smirnov), test statistic (T independent test or Mann Whitney test, Anova test)

Official Title
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THE EFFECT OF VITAMIN D SUPPLEMENTATION ON IMPROVING PANCREAS BETA CELL FUNCTION IN TYPE 2 DIABETES MELLITUS: STUDY OF SOD,IL-6,PDX-1 EXPRESSION, and INSULIN RESISTANCE

Conditions
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Type2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Vitamin D 5000 IU
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male and female, aged > 18 years period of DM ≤ 3 years using a single anti-diabetic drug (monotherapy) HbA1c > 6,5% Exclusion Criteria: receive insulin therapy kidney disease, liver disease pregnant and lactating women allergy history hypercalcemia history consumption of vitamin D in the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study was divided into two groups, the intervention group and the control group. The intervention group received vitamin D 5000 IU/day for 6 months and the control group received a placebo (contains microcrystalline, calcium carbonate, sodium starch) for 6 months
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Vitamin D, dosage form chewable tablet, dosage 5000 IU, frequency every day, duration six months | Dietary Supplement: Vitamin D 5000 IU<br>* Intervention vitamin D 5000 IU per day, duration six months, dosage form chewable tablet<br>|
| Placebo Comparator: control group<br>Placebo (microcrystalline,calcium carbonate, sodium starch), dosage form chewable tablet, frequency every day, duration six month | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of Superoxide Dismutase (SOD) | SOD | Change from Baseline at 3 and 6 months | 
| Interleukin-6 (IL-6) | IL-6 in monocyte: % (method immunoflowcytometry); | Change from Baseline at 3 and 6 months | 
| pancreatic and duodenal homeobox 1(PDX-1) expression | PDX-1 expression : ct (method polymerase chain reaction /PCR); | Change from Baseline at 3 and 6 months | 
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | HOMA-IR : formula (fasting insulin (μIU/mL) x fasting blood glucose (mg/dL)/405 | Change from Baseline at 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vitamin D level | Vitamin D: ng/mL; | Change from Baseline at 3 and 6 months | 
| (hemoglobin glycate) HbA1C | HbA1c: % ; | Change from Baseline at 3 and 6 months | 
| fasting blood glucose | Fasting blood glucose: mg/dL ; | Change from Baseline at 3 and 6 months | 
| fasting insulin | Fasting insulin: μIU/mL | Change from Baseline at 3 and 6 months |