Effect of Vitamin B12 Supplementation on Glycaemic Control in Uncontrolled Hyperhomocysteinemic Type 2 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- To compare the change in HbA1c levels (%) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients
研究概览
简要总结
Increased plasma homocysteine level is associated with macroangiopathy and nephropathy in type 2 diabetes. Also increased levels of serum homocysteine are associated with microalbuminuria which is associated with increased cardiovascular morbidity and mortality among the patients with type 2 diabetes. With B12 supplementation homocysteine level can be reduced .Type 2 diabetes as a metabolic syndrome may show improvement in glycaemic control with Vitamin B12 therapy as there is correction of hyperhomocysteinemia. In studies it is proved that combination of vit B12, folic acid and vit B6 are effective for hyperhomocysteinemia.There are no such separate trials on the use of vit B12 alone. This therapy may be used in large number of type 2 uncontrolled diabetic hyperhomocysteinemic patients.
this study was planned with following objectives to study effect of Vitamin B12 supplementation on glycaemic control in poorly controlled hyperhomocysteinemic type 2 diabetic patients
- Glycaemic control measured by levels of glycosylated haemoglobin (HbA1c) at baseline and 4 weeks
- Fasting blood sugar level at baseline and 4 weeks
- Serum homocysteine/ vitamin B12 levels at baseline and 4 weeks
- Serum lipid profile at baseline and 4 weeks
详细描述
After approval from Institutional Ethics Committee, patients not responding adequately to oral anti-diabetic agents were recruited from Medicine out patient department (OPD) with the help of treating physician. Patient were first screened for serum homocysteine/vitamin B12 level along with all baseline investigations. Those having serum homocysteine level more than 15 umol/L or vitamin B12 level less than 223pg/ml were enrolled in this study. Due to high cost for investigation serum homocysteine level was measured only in 6 patients and serum vitamin B12 level (cheaper test) was measured in 14 patients with prior permission from Ethics Committee. Patients were given all the information about Vitamin B12 (methylcobalamin) including adverse effects. A written informed consent was taken from each patient and those who were willing to participate in study were enrolled in this study. All the information was recorded in case report forms.
There were two groups of poorly controlled patient; one group (DRUG GROUP) received methylcobalamin 500 ug daily with their usual antidiabetic therapy and the other group (CONTROL GROUP) received suitable antidiabetic drug therapy as prescribed by treating physician. Methylcobalamin 500ug was given once daily for the period of 4 weeks and were followed-up at 4 weeks. At Baseline all the investigations were carried out as follows:
Study Flow Chart
Baseline Serum Homocysteine.n=6 (DRUG GROUP), Serum Vitamin B12, n=14 (DRUG GROUP), n=18 (CONTROL GROUP) Body weight, height, Blood pressure,glycosylated hemoglobin (HbA1c) level, Blood sugar-Fasting/Postprandial, Serum lipid profile( to measure the effect of Vitamin B12), Blood urea, Serum creatinine, Serum Bilirubin, Serum glutamate oxaloacetate transaminase (SGOT),Serum glutamate pyruvate transaminase (SGPT), Alkaline phosphatase ( to rule out hepatic or renal dysfunction ), Routine urine examination for albumin, Electrocardiogram (ECG):to rule out cardiac abnormality viz, IHD, arrhythmias
4 Weeks Body weight, Blood pressure, glycosylated hemoglobin(HbA1c) level, Blood sugar-Fasting/Postprandial, Serum lipid profile, Serum homocysteine/ serum vitamin B12, Urine albumin examination
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30 -70 years
- •Sex: Male/ Non-lactating female
- •Glycosylated hemoglobin (HbA1c) > 8
- •Serum Homocysteine > 15 umol / L or vitamin B12 less than 223pg/ml
排除标准
- •Age < 30 yrs.
- •Lactating mother
- •Patient with Insulin dependent diabetes mellitus
- •Severe and Complicated diabetes mellitus
- •Patient with hepatic or renal dysfunction
研究组 & 干预措施
Vitamin B12 and Antidiabetics
Tablet Methylcobalamin 500 ug once daily with other usual antidiabetic drugs
干预措施: METHYLCOBALAMIN 500 micrograms (Dietary Supplement)
antidiabetics
Only regular antidiabetic drugs will be given
结局指标
主要结局
To compare the change in HbA1c levels (%) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients
时间窗: baseline and 4 weeks
次要结局
- To compare the change in high density lipoprotein(HDL),low density lipoprotein(LDL) and total cholesterol in mg/dL with vitamin B12 supplementation in poorly controlled type 2 diabetic patients(baseline and 4 weeks)
- To compare the change in fasting and postprandial blood sugar levels (mg/dL) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients(baseline and 4 weeks)
- To compare the change in serum homocysteine level (micromol/L) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients(baseline and 4 weeks)
研究者
Dr Yogendra Keche
Associate Professor
Smt. Kashibai Navale Medical College and General Hospital