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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.
The biochemical parameters will be evaluated before and after the intervention.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Folic acid | Experimental | 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 |
|
| Vitamin B12 | Experimental | 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 |
|
| "Folic acid" and "Vitamin B12" | Experimental | 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 |
|
| Control | Active Comparator | Twenty type-2 diabetes patients with standard Oral hypoglycemic agents [Metformin +/- Sulfonylurea] will be recruited and receive no additional supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folic acid | Dietary Supplement | tab. Folic acid 5 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose | 8 weeks | |
| Fasting plasma insulin | 8 weeks | |
| Insulin Resistance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debapriya Bandyopadhyay, M.D. | All India Institute of Medical Sciences, Bhubaneswar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All India Institute of Medical Sciences, Bhubaneswar | Bhubaneswar | Odisha | 751019 | India |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| D014805 | Vitamin B 12 |
| D007004 | Hypoglycemic Agents |
| D008687 | Metformin |
| D013453 | Sulfonylurea Compounds |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Vitamin B12 | Dietary Supplement | tab. Vitamin B12 500 mcg |
|
| Oral hypoglycemic agents [Metformin +/- Sulfonylurea] | Drug | Patients receiving either of the following oral hypoglycemic agents
|
|
|
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 |
| D004700 | Endocrine System Diseases |
| D006571 | Heterocyclic Compounds |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014508 | Urea |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |