Type 2 DiabetesNCT02540642
Effect of Vitamin B12 Supplementation on Glycaemic Control in Uncontrolled Hyperhomocysteinemic Type 2 Diabetic Patients
A study testing METHYLCOBALAMIN 500 micrograms in people with Type 2 Diabetes and Vitamin B12 Deficiency, run by Smt. Kashibai Navale Medical College and General Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes, Vitamin B12 Deficiency, Hyperhomocysteinemia
- What is being tested?
- METHYLCOBALAMIN 500 micrograms
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2010to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age < 30 yrs.
- Pregnancy
- Lactating mother
- Patient with Insulin dependent diabetes mellitus
- Severe and Complicated diabetes mellitus
- Patient with hepatic or renal dysfunction
Trial locations and contacts
1 site in 1 country.
India1 site
Smt Kashibai Navale Medical College and Hospital
Pune, Maharashtra, 411041
About this study
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
Read the 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.
- Being tested
- METHYLCOBALAMIN 500 micrograms
- Medical subject headings
- Diabetes Mellitus, Type 2, Vitamin B 12 Deficiency, Hyperhomocysteinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
METHYLCOBALAMIN 500 microgramsDietary supplement
Also called Vitamin B12
Tab Methycobalamin 500 ug will be given with other regular antidiabetic drugs
| Study group | Role | What they receive |
|---|---|---|
| Vitamin B12 and Antidiabetics | Active comparator | Tablet Methylcobalamin 500 ug once daily with other usual antidiabetic drugs Receives: Dietary Supplement: METHYLCOBALAMIN 500 micrograms |
| antidiabetics | No intervention | Only regular antidiabetic drugs will be given |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the change in HbA1c levels (%) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients
Measured: baseline and 4 weeks
Secondary outcomes (3)
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
Measured: baseline and 4 weeks
To compare the change in fasting and postprandial blood sugar levels (mg/dL) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients
Measured: baseline and 4 weeks
To compare the change in serum homocysteine level (micromol/L) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startOct 2010
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smt. Kashibai Navale Medical College and General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Yogendra Keche, Smt. Kashibai Navale Medical College and General Hospital
- Investigators
- YOGENDRA N KECHE, MD, Principal investigator, SMT KASHIBAI NAVALE MEDICAL COLLEGE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540642
- Sponsor's protocol ID
- SKNMC No./Ethics/App/2010/45
- Status last verified
- Mar 2018
- First submitted
- 27 Aug 2015
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin B12 Supplementation on Glycaemic Control in Uncontrolled Hyperhomocysteinemic Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02540642
- Acronym / sponsor ID
- SKNMC No./Ethics/App/2010/45
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Smt. Kashibai Navale Medical College and General HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin B12 and Antidiabetics | Active comparator | Dietary Supplement: METHYLCOBALAMIN 500 microgramsTablet Methylcobalamin 500 ug once daily with other usual antidiabetic drugs |
| antidiabetics | No intervention | –Only regular antidiabetic drugs will be given |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Age < 30 yrs.
- Pregnancy
- Lactating mother
- Patient with Insulin dependent diabetes mellitus
- Severe and Complicated diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| METHYLCOBALAMIN 500 microgramsAlso: Vitamin B12Tab Methycobalamin 500 ug will be given with other regular antidiabetic drugs | Dietary supplement | Vitamin B12 and Antidiabetics |
Primary outcome
To compare the change in HbA1c levels (%) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients
Time frame: baseline and 4 weeks
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YOGENDRA N KECHE, MD principal investigator
SMT KASHIBAI NAVALE MEDICAL COLLEGE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing METHYLCOBALAMIN 500 micrograms in people with Type 2 Diabetes and Vitamin B12 Deficiency, run by Smt. Kashibai Navale Medical College and General Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the change in HbA1c levels (%) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients (time frame: baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.