Type 2 Diabetes Clinical Trial
Official title:
Effect of Vitamin B12 Supplementation on Glycaemic Control in Uncontrolled Hyperhomocysteinemic Type 2 Diabetic Patients
Verified date | March 2018 |
Source | Smt. Kashibai Navale Medical College and General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 38 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Age between 30 -70 years 2. Sex: Male/ Non-lactating female 3. Glycosylated hemoglobin (HbA1c) > 8 4. Serum Homocysteine > 15 umol / L or vitamin B12 less than 223pg/ml Exclusion Criteria: 1. Age < 30 yrs. 2. Pregnancy 3. Lactating mother 4. Patient with Insulin dependent diabetes mellitus 5. Severe and Complicated diabetes mellitus 6. Patient with hepatic or renal dysfunction |
Country | Name | City | State |
---|---|---|---|
India | Smt Kashibai Navale Medical College and Hospital | Pune | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Smt. Kashibai Navale Medical College and General Hospital |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the change in HbA1c levels (%) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients | baseline and 4 weeks | ||
Secondary | To compare the change in high density lipoprotein(HDL),low density lipoprotein(LDL) and total cholesterol in mg/dL with vitamin B12 supplementation in poorly controlled type 2 diabetic patients | baseline and 4 weeks | ||
Secondary | To compare the change in fasting and postprandial blood sugar levels (mg/dL) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients | baseline and 4 weeks | ||
Secondary | To compare the change in serum homocysteine level (micromol/L) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients | baseline and 4 weeks |
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