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

NCT02786823 | Completed Phase 2

• 1 other identifier: T/lM-F/Biochem/15/22
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c

  8 weeks

Secondary Outcomes (13)

• Fasting plasma glucose

  8 weeks

• Fasting plasma insulin

  8 weeks

• Insulin Resistance

  8 weeks

• Serum total cholesterol

  8 weeks

• Serum triacylglycerol

  8 weeks

Study Arms (4)

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

Dietary Supplement: Folic acid; Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]

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

Dietary Supplement: Vitamin B12; Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]

"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

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

Control

ACTIVE COMPARATOR

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]

Interventions

Folic acid DIETARY_SUPPLEMENT

tab. Folic acid 5 mg

"Folic acid" and "Vitamin B12"; Folic acid

Vitamin B12 DIETARY_SUPPLEMENT

tab. Vitamin B12 500 mcg

"Folic acid" and "Vitamin B12"; Vitamin B12

Oral hypoglycemic agents [Metformin +/- Sulfonylurea] DRUG

Patients receiving either of the following oral hypoglycemic agents 1. Sulfonylurea 2. Metformin 3. Metformin plus Sulfonylurea

Also known as: Metformin, Sulfonylurea

"Folic acid" and "Vitamin B12"; Control; Folic acid; Vitamin B12

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

All India Institute of Medical Sciences, Bhubaneswar

Bhubaneswar, Odisha, 751019, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Folic Acid; Vitamin B 12; Hypoglycemic Agents; Metformin; Sulfonylurea Compounds

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Biguanides; Guanidines; Amidines; Organic Chemicals; Urea; Amides; Sulfones; Sulfur Compounds

Study Officials

• Debapriya Bandyopadhyay, M.D.

  All India Institute of Medical Sciences, Bhubaneswar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Biochemistry, All India Institute of Medical Sciences, Bhubaneswar

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 1, 2016
• Study Start: May 1, 2017
• Primary Completion: August 15, 2017
• Study Completion: September 15, 2017
• Last Updated: September 19, 2017

Record last verified: 2017-09

Locations

IN (1)