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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- level of Superoxide Dismutase (SOD)
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female, aged > 18 years
- •period of DM ≤ 3 years
- •using a single anti-diabetic drug (monotherapy)
- •HbA1c > 6,5%
排除标准
- •receive insulin therapy
- •kidney disease, liver disease
- •pregnant and lactating women
- •allergy history
- •hypercalcemia history
- •consumption of vitamin D in the last 3 months
结局指标
主要结局
level of Superoxide Dismutase (SOD)
时间窗: Change from Baseline at 3 and 6 months
SOD
Interleukin-6 (IL-6)
时间窗: Change from Baseline at 3 and 6 months
IL-6 in monocyte: % (method immunoflowcytometry);
pancreatic and duodenal homeobox 1(PDX-1) expression
时间窗: Change from Baseline at 3 and 6 months
PDX-1 expression : ct (method polymerase chain reaction /PCR);
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
时间窗: Change from Baseline at 3 and 6 months
HOMA-IR : formula (fasting insulin (μIU/mL) x fasting blood glucose (mg/dL)/405
次要结局
- vitamin D level(Change from Baseline at 3 and 6 months)
- (hemoglobin glycate) HbA1C(Change from Baseline at 3 and 6 months)
- fasting blood glucose(Change from Baseline at 3 and 6 months)
- fasting insulin(Change from Baseline at 3 and 6 months)
研究者
dr Alvina Alvina,SpPK
clinical pathology specialist
Trisakti University