Effect of Folic Acid and Vitamin B12 Supplementation in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The results of all the parameters evaluated will be recorded in the subject's Data Collection Form.The data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 21.

Official Title
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Effect of Folic Acid and Vitamin B12 Supplementation on Biochemical Parameters in Subjects With Type-2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: Folic acid
* Dietary Supplement: Vitamin B12
* Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 % Smoking 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Folic acid<br>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 | Dietary Supplement: Folic acid<br>* tab. Folic acid 5 mg<br>Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]<br>* Patients receiving either of the following oral hypoglycemic agents Sulfonylurea Metformin Metformin plus Sulfonylurea<br>* Other names: Metformin, Sulfonylurea;|
| Experimental: Vitamin B12<br>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 | Dietary Supplement: Vitamin B12<br>* tab. Vitamin B12 500 mcg<br>Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]<br>* Patients receiving either of the following oral hypoglycemic agents Sulfonylurea Metformin Metformin plus Sulfonylurea<br>* Other names: Metformin, Sulfonylurea;|
| Experimental: Folic acid and Vitamin B12<br>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 | Dietary Supplement: Folic acid<br>* tab. Folic acid 5 mg<br>Dietary Supplement: Vitamin B12<br>* tab. Vitamin B12 500 mcg<br>Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]<br>* Patients receiving either of the following oral hypoglycemic agents Sulfonylurea Metformin Metformin plus Sulfonylurea<br>* Other names: Metformin, Sulfonylurea;|
| Active Comparator: Control<br>Twenty type-2 diabetes patients with standard Oral hypoglycemic agents [Metformin +/- Sulfonylurea] will be recruited and receive no additional supplementation | Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]<br>* Patients receiving either of the following oral hypoglycemic agents Sulfonylurea Metformin Metformin plus Sulfonylurea<br>* Other names: Metformin, Sulfonylurea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose |  | 8 weeks | 
| Fasting plasma insulin |  | 8 weeks | 
| Insulin Resistance | Using Homeostatic model assessment (HOMA2 calculator which uses fasting plasma glucose and plasma insulin values to calculate insulin resistance) | 8 weeks | 
| Serum total cholesterol |  | 8 weeks | 
| Serum triacylglycerol |  | 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 Tumor Necrosis Factor (TNF) |  | 8 weeks | 
| Serum Interleukin-6 (IL-6) |  | 8 weeks | 
| Serum C reactive protein (CRP) |  | 8 weeks |