Efficacy of two doses( 500mcg and 1000mcg) of Vitamin B12 supplementation on glycemic control in poorly controlled type 2 diabetic patients with hyperhomocysteinemia

Phase 4

Completed

Conditions: Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

Registration Number: CTRI/2022/08/044720

Lead Sponsor: All India Institute of Medical sciences Raipur

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Male,non-lactating female above the age of 30 years, diagnosed with type 2 diabetes mellitus and who are poorly controlled

2. HBA1c > 7%

3.Vitamin B12 levels < 211 pg/ml

4. Homocysteine levels >15 mcgmol/

Exclusion Criteria

1. Patients who were on non-allopathic forms of treatment for glycemic control

2.Patients receiving insulin

3. Patients having diagnosed of renal function abnormalities with eGFR <60

4.Patients diagnosed of liver function abnormalities

5. Patients with insulin dependent diabetes mellitus, severe and complicated diabetes, pregnancy and lactating mother

Anaemic patients with HBA1c <1 0 gm/floor

6.Patients on vitamin B12 supplementation

7. Patients on drugs affecting glucose metabolism such as fluoroquinolones, phenytoin

Patients who presented with alcoholism, gastrectomy, gastric by pass surgery, pancreatic insufficiency, malabsorption syndromes chronic giardiasis or surgery involving small intestine.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean changes in the HBA1c level from the baseline value at the end of 8 weeks therapyTimepoint: First visit (baseline, 0 weeks) <br/ ><br>Second visit( 8th week) <br/ ><br>Third visit ( 6th month)

Secondary Outcome Measures

Name	Time	Method
1.Mean changes in the homocysteine level from the baseline value at the end of 8 weeks therapy <br/ ><br>2. Mean changes in the fasting blood glucose level from baseline at the end of 8 weeks therapy <br/ ><br>3.Mean changes in the plasma insulin level from the baseline value at the end of 8 weeks therapy <br/ ><br>4. Mean changes in the parameters of lipid profile levels from the baseline value at the end of 8 weeks therapy <br/ ><br>5. Mean changes in the HBA1c level at the end of 6 month follow up <br/ ><br>6. Mean changes in the fasting blood glucose level at the end of 6 month follow upTimepoint: First visit( baseline, 0 weeks) <br/ ><br>Second visit( 8th week <br/ ><br>Third visit ( 6th month) <br/ ><br>