Effect of Vitamin B12 Supplementation on Glycaemic Control in Uncontrolled Hyperhomocysteinemic Type 2 Diabetic Patients
Primary Purpose
Type 2 Diabetes, Vitamin B12 Deficiency, Hyperhomocysteinemia
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
METHYLCOBALAMIN 500 micrograms
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Age between 30 -70 years
- Sex: Male/ Non-lactating female
- Glycosylated hemoglobin (HbA1c) > 8
- Serum Homocysteine > 15 umol / L or vitamin B12 less than 223pg/ml
Exclusion Criteria:
- Age < 30 yrs.
- Pregnancy
- Lactating mother
- Patient with Insulin dependent diabetes mellitus
- Severe and Complicated diabetes mellitus
- Patient with hepatic or renal dysfunction
Sites / Locations
- Smt Kashibai Navale Medical College and Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Vitamin B12 and Antidiabetics
antidiabetics
Arm Description
Tablet Methylcobalamin 500 ug once daily with other usual antidiabetic drugs
Only regular antidiabetic drugs will be given
Outcomes
Primary Outcome Measures
To compare the change in HbA1c levels (%) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients
Secondary Outcome Measures
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
To compare the change in fasting and postprandial blood sugar levels (mg/dL) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients
To compare the change in serum homocysteine level (micromol/L) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients
Full Information
NCT ID
NCT02540642
First Posted
August 27, 2015
Last Updated
March 14, 2018
Sponsor
Smt. Kashibai Navale Medical College and General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02540642
Brief Title
Effect of Vitamin B12 Supplementation on Glycaemic Control in Uncontrolled Hyperhomocysteinemic Type 2 Diabetic Patients
Official Title
Effect of Vitamin B12 Supplementation on Glycaemic Control in Uncontrolled Hyperhomocysteinemic Type 2 Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Smt. Kashibai Navale Medical College and General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
Glycaemic control measured by levels of glycosylated haemoglobin (HbA1c) at baseline and 4 weeks
Fasting blood sugar level at baseline and 4 weeks
Serum homocysteine/ vitamin B12 levels at baseline and 4 weeks
Serum lipid profile at baseline and 4 weeks
Detailed Description
After approval from Institutional Ethics Committee, patients not responding adequately to oral anti-diabetic agents were recruited from Medicine out patient department (OPD) with the help of treating physician. Patient were first screened for serum homocysteine/vitamin B12 level along with all baseline investigations. Those having serum homocysteine level more than 15 umol/L or vitamin B12 level less than 223pg/ml were enrolled in this study. Due to high cost for investigation serum homocysteine level was measured only in 6 patients and serum vitamin B12 level (cheaper test) was measured in 14 patients with prior permission from Ethics Committee. Patients were given all the information about Vitamin B12 (methylcobalamin) including adverse effects. A written informed consent was taken from each patient and those who were willing to participate in study were enrolled in this study. All the information was recorded in case report forms.
There were two groups of poorly controlled patient; one group (DRUG GROUP) received methylcobalamin 500 ug daily with their usual antidiabetic therapy and the other group (CONTROL GROUP) received suitable antidiabetic drug therapy as prescribed by treating physician. Methylcobalamin 500ug was given once daily for the period of 4 weeks and were followed-up at 4 weeks. At Baseline all the investigations were carried out as follows:
Study Flow Chart
Baseline Serum Homocysteine.n=6 (DRUG GROUP), Serum Vitamin B12, n=14 (DRUG GROUP), n=18 (CONTROL GROUP) Body weight, height, Blood pressure,glycosylated hemoglobin (HbA1c) level, Blood sugar-Fasting/Postprandial, Serum lipid profile( to measure the effect of Vitamin B12), Blood urea, Serum creatinine, Serum Bilirubin, Serum glutamate oxaloacetate transaminase (SGOT),Serum glutamate pyruvate transaminase (SGPT), Alkaline phosphatase ( to rule out hepatic or renal dysfunction ), Routine urine examination for albumin, Electrocardiogram (ECG):to rule out cardiac abnormality viz, IHD, arrhythmias
4 Weeks Body weight, Blood pressure, glycosylated hemoglobin(HbA1c) level, Blood sugar-Fasting/Postprandial, Serum lipid profile, Serum homocysteine/ serum vitamin B12, Urine albumin examination
After enrollment of patient for study, All the baseline investigations will be carried out at Central Clinical Laboratory except glycosylated haemoglobin which was carried out at department of Pharmacology and homocysteine estimation which was carried out in an accredited laboratory. ECG, Blood pressure recording was carried out in Department of Medicine.
Reporting of Adverse effects: All patients had been given checklist of adverse effect of vitamin B12. Information of adverse drug reactions (ADRs ) was taken in next follow-up. If patients are unable tolerate adverse drug reactions they were advised to contact any of investigators at any time. Contact numbers of investigators was mentioned on patient information sheet.
Expected adverse drug reactions of vitamin B12 : Anorexia, Nausea, Vomiting, Diarrhea and Rash
Sample Size Calculation and statistical analysis:
Sample size of 20 for each group was calculated in the ratio of 1, power 80 %, considering 10 fold difference of drug effect in vitamin B12 group and control group by using Open Epi 2.3(2009). Randomization was done with the help of randomization software Rando 1.2,2004. Statistical analysis was done by using Open Epi 2.3(2009) and Microsoft Excel.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Vitamin B12 Deficiency, Hyperhomocysteinemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin B12 and Antidiabetics
Arm Type
Active Comparator
Arm Description
Tablet Methylcobalamin 500 ug once daily with other usual antidiabetic drugs
Arm Title
antidiabetics
Arm Type
No Intervention
Arm Description
Only regular antidiabetic drugs will be given
Intervention Type
Dietary Supplement
Intervention Name(s)
METHYLCOBALAMIN 500 micrograms
Other Intervention Name(s)
Vitamin B12
Intervention Description
Tab Methycobalamin 500 ug will be given with other regular antidiabetic drugs
Primary Outcome Measure Information:
Title
To compare the change in HbA1c levels (%) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients
Time Frame
baseline and 4 weeks
Secondary Outcome Measure Information:
Title
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
Time Frame
baseline and 4 weeks
Title
To compare the change in fasting and postprandial blood sugar levels (mg/dL) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients
Time Frame
baseline and 4 weeks
Title
To compare the change in serum homocysteine level (micromol/L) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients
Time Frame
baseline and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 30 -70 years
Sex: Male/ Non-lactating female
Glycosylated hemoglobin (HbA1c) > 8
Serum Homocysteine > 15 umol / L or vitamin B12 less than 223pg/ml
Exclusion Criteria:
Age < 30 yrs.
Pregnancy
Lactating mother
Patient with Insulin dependent diabetes mellitus
Severe and Complicated diabetes mellitus
Patient with hepatic or renal dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YOGENDRA N KECHE, MD
Organizational Affiliation
SMT KASHIBAI NAVALE MEDICAL COLLEGE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Smt Kashibai Navale Medical College and Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411041
Country
India
12. IPD Sharing Statement
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Effect of Vitamin B12 Supplementation on Glycaemic Control in Uncontrolled Hyperhomocysteinemic Type 2 Diabetic Patients
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