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Effect of Vitamin B12 Supplementation on Glycaemic Control in Uncontrolled Hyperhomocysteinemic Type 2 Diabetic Patients

NCT02540642 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-03-15

No results posted yet for this study

Summary

Increased plasma homocysteine level is associated with macroangiopathy and nephropathy in type 2 diabetes. Also increased levels of serum homocysteine are associated with microalbuminuria which is associated with increased cardiovascular morbidity and mortality among the patients with type 2 diabetes. With B12 supplementation homocysteine level can be reduced .Type 2 diabetes as a metabolic syndrome may show improvement in glycaemic control with Vitamin B12 therapy as there is correction of hyperhomocysteinemia. In studies it is proved that combination of vit B12, folic acid and vit B6 are effective for hyperhomocysteinemia.There are no such separate trials on the use of vit B12 alone. This therapy may be used in large number of type 2 uncontrolled diabetic hyperhomocysteinemic patients.

this study was planned with following objectives to study effect of Vitamin B12 supplementation on glycaemic control in poorly controlled hyperhomocysteinemic type 2 diabetic patients

1. Glycaemic control measured by levels of glycosylated haemoglobin (HbA1c) at baseline and 4 weeks
2. Fasting blood sugar level at baseline and 4 weeks
3. Serum homocysteine/ vitamin B12 levels at baseline and 4 weeks
4. Serum lipid profile at baseline and 4 weeks

Conditions

Interventions

DIETARY_SUPPLEMENT

METHYLCOBALAMIN 500 micrograms

Tab Methycobalamin 500 ug will be given with other regular antidiabetic drugs

Sponsors & Collaborators

  • Smt. Kashibai Navale Medical College and General Hospital

    lead OTHER

Principal Investigators

  • YOGENDRA N KECHE, MD · SMT KASHIBAI NAVALE MEDICAL COLLEGE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02540642 on ClinicalTrials.gov