A Phase 2/3 interventional study of Folic acid and Vitamin B12 in Diabetes Mellitus, Type 2, sponsored by All India Institute of Medical Sciences, Bhubaneswar. Completed at 1 site in India. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-09-19.
Sponsored by All India Institute of Medical Sciences, Bhubaneswar · Phase 2/3, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 80 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →All India Institute of Medical Sciences, Bhubaneswar is the lead sponsor of 59 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]
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 · Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]
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 · Dietary Supplement: Vitamin B12 · Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]
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]
tab. Folic acid 5 mg
tab. Vitamin B12 500 mcg
Patients receiving either of the following oral hypoglycemic agents 1. Sulfonylurea 2. Metformin 3. Metformin plus Sulfonylurea
Also known as: Metformin, Sulfonylurea
HbA1c
Time frame: 8 weeks
Fasting plasma glucose
Time frame: 8 weeks
Fasting plasma insulin
Time frame: 8 weeks
Insulin Resistance
Using Homeostatic model assessment (HOMA2 calculator which uses fasting plasma glucose and plasma insulin values to calculate insulin resistance)
Time frame: 8 weeks
Serum total cholesterol
Time frame: 8 weeks
Serum triacylglycerol
Time frame: 8 weeks
Serum Low-density lipoprotein (LDL)
Time frame: 8 weeks
Serum High-density lipoprotein (HDL)
Time frame: 8 weeks
Serum Very Low-density lipoprotein (VLDL)
Time frame: 8 weeks
Serum Homocysteine
Time frame: 8 weeks
Serum Adiponectin
Time frame: 8 weeks
Serum Tumor Necrosis Factor (TNF)
Time frame: 8 weeks
Serum Interleukin-6 (IL-6)
Time frame: 8 weeks
Serum C reactive protein (CRP)
Time frame: 8 weeks
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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All India Institute of Medical Sciences, Bhubaneswar