Effect of Folic Acid and Vitamin B12 Supplementation on Biochemical Parameters in Subjects With Type-2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
This study aims to evaluate the effect of Folic acid and Vitamin B12 supplementation on Biochemical parameters in subjects with type-2 Diabetes. 80 selected subjects will be divided into 4 groups of 20 each.
- Group A: to receive Folic acid 5 mg once daily for 8 weeks along with standard oral anti-diabetic drugs;
- Group B: to receive Vitamin B12 500 mcg once daily for 8 weeks along with standard oral anti-diabetic drugs;
- Group C: to receive both Folic acid 5 mg once daily and Vitamin B12 500 mcg once daily for 8 weeks along with standard oral anti-diabetic drugs;
- Group D: to receive no additional intervention apart from standard oral anti-diabetic drugs.
The biochemical parameters will be evaluated before and after the intervention.
详细描述
This is a randomized, parallel group, open label study to evaluate the effect of Folic acid and Vitamin B12 supplementation on Biochemical parameters in subjects with type-2 Diabetes.
80 selected subjects will be randomly assigned to 4 groups of 20 each as follows:
- Group A: to receive Folic acid 5 mg once daily for 8 weeks along with standard oral anti-diabetic drugs;
- Group B: to receive Vitamin B12 500 mcg once daily for 8 weeks along with standard oral anti-diabetic drugs;
- Group C: to receive both Folic acid 5 mg once daily and Vitamin B12 500 mcg once daily for 8 weeks along with standard oral anti-diabetic drugs;
- Group D: to receive no additional intervention apart from standard oral anti-diabetic drugs.
The subjects will also be advised to be on a normal routine diet, not to skip any meal and not to change their exercise pattern (if any) during the study period.The compliance of the intervention will be monitored by instructing the patients to return all unused tablets at the end of the 8 weeks period of study.
All the subjects will be asked to report after an overnight fasting of 12 hours on two occasions i.e. at the start of the study before allocation of group and 8 weeks after allocation. After measurement of body weight, height and blood pressure (by Mercury Sphygmomanometer), 5 milliliter of early morning fasting venous blood sample will be collected under aseptic measures on both the occasions. The samples collected will then be appropriately processed for the analysis of various biochemical parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetic patients within age group 30-65 years, on stable dose of anti-diabetic with/without anti-hypertensive drugs will be included in this study
排除标准
- •Subjects on non-allopathic forms of treatment for diabetic control.
- •Subjects with Chronic Renal disease and Liver disease.
- •Subjects with malabsorption.
- •Subjects with Thyroid function abnormalities.
- •HbA1c levels more than 10 %
- •Alcoholism
- •Pregnant subjects
- •Subjects with vitamin B12 deficiency
- •Subjects already on Folate or Vitamin B12 supplementation due to some other medical condition
- •The detailed drug history of the subjects will be taken prior to including them in the study. Antibiotics like Fluoroquinolones; anti-seizure drugs like phenytoin; Corticosteroids and Hormonal Contraceptives; Hypolipidemic drugs like statins are known to affect Glucose metabolism and subjects on these medications will not be included in the study.
研究组 & 干预措施
Folic acid
Twenty type-2 diabetes patients with standard Oral hypoglycemic agents [Metformin +/- Sulfonylurea] will be recruited and additionally receive tab. Folic acid 5 mg once daily for 8 weeks
干预措施: Folic acid (Dietary Supplement)
Folic acid
Twenty type-2 diabetes patients with standard Oral hypoglycemic agents [Metformin +/- Sulfonylurea] will be recruited and additionally receive tab. Folic acid 5 mg once daily for 8 weeks
干预措施: Oral hypoglycemic agents [Metformin +/- Sulfonylurea] (Drug)
Vitamin B12
Twenty type-2 diabetes patients with standard Oral hypoglycemic agents [Metformin +/- Sulfonylurea] will be recruited and additionally receive tab. Vitamin B12 500 mcg once daily for 8 weeks
干预措施: Vitamin B12 (Dietary Supplement)
Vitamin B12
Twenty type-2 diabetes patients with standard Oral hypoglycemic agents [Metformin +/- Sulfonylurea] will be recruited and additionally receive tab. Vitamin B12 500 mcg once daily for 8 weeks
干预措施: Oral hypoglycemic agents [Metformin +/- Sulfonylurea] (Drug)
"Folic acid" and "Vitamin B12"
Twenty type-2 diabetes patients with standard Oral hypoglycemic agents [Metformin +/- Sulfonylurea] will be recruited and additionally receive both tab. Folic acid 5 mg once daily and tab. Vitamin B12 500 mcg once daily for 8 weeks
干预措施: Folic acid (Dietary Supplement)
"Folic acid" and "Vitamin B12"
Twenty type-2 diabetes patients with standard Oral hypoglycemic agents [Metformin +/- Sulfonylurea] will be recruited and additionally receive both tab. Folic acid 5 mg once daily and tab. Vitamin B12 500 mcg once daily for 8 weeks
干预措施: Vitamin B12 (Dietary Supplement)
"Folic acid" and "Vitamin B12"
Twenty type-2 diabetes patients with standard Oral hypoglycemic agents [Metformin +/- Sulfonylurea] will be recruited and additionally receive both tab. Folic acid 5 mg once daily and tab. Vitamin B12 500 mcg once daily for 8 weeks
干预措施: Oral hypoglycemic agents [Metformin +/- Sulfonylurea] (Drug)
Control
Twenty type-2 diabetes patients with standard Oral hypoglycemic agents [Metformin +/- Sulfonylurea] will be recruited and receive no additional supplementation
干预措施: Oral hypoglycemic agents [Metformin +/- Sulfonylurea] (Drug)
结局指标
主要结局
HbA1c
时间窗: 8 weeks
次要结局
- Insulin Resistance(8 weeks)
- Serum triacylglycerol(8 weeks)
- Serum Tumor Necrosis Factor (TNF)(8 weeks)
- Serum Low-density lipoprotein (LDL)(8 weeks)
- Serum High-density lipoprotein (HDL)(8 weeks)
- Serum Very Low-density lipoprotein (VLDL)(8 weeks)
- Serum Homocysteine(8 weeks)
- Serum Adiponectin(8 weeks)
- Serum C reactive protein (CRP)(8 weeks)
- Fasting plasma glucose(8 weeks)
- Fasting plasma insulin(8 weeks)
- Serum total cholesterol(8 weeks)
- Serum Interleukin-6 (IL-6)(8 weeks)
研究者
Dr. Debapriya Bandyopadhyay
Assistant Professor, Department of Biochemistry, All India Institute of Medical Sciences, Bhubaneswar
All India Institute of Medical Sciences, Bhubaneswar