NCT02540642

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

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

4.6 years

First QC Date

August 27, 2015

Last Update Submit

March 14, 2018

Conditions

Type 2 DiabetesVitamin B12 DeficiencyHyperhomocysteinemia

Outcome Measures

Primary Outcomes (1)

  • To compare the change in HbA1c levels (%) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients

    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

    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

    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

    baseline and 4 weeks

Study Arms (2)

Vitamin B12 and Antidiabetics

ACTIVE COMPARATOR

Tablet Methylcobalamin 500 ug once daily with other usual antidiabetic drugs

Dietary Supplement: METHYLCOBALAMIN 500 micrograms

antidiabetics

NO INTERVENTION

Only regular antidiabetic drugs will be given

Interventions

METHYLCOBALAMIN 500 microgramsDIETARY_SUPPLEMENT

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

Also known as: Vitamin B12
Vitamin B12 and Antidiabetics

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 30 yrs.
  • Pregnancy
  • Lactating mother
  • Patient with Insulin dependent diabetes mellitus
  • Severe and Complicated diabetes mellitus
  • Patient with hepatic or renal dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Smt Kashibai Navale Medical College and Hospital

Pune, Maharashtra, 411041, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Vitamin B 12 DeficiencyHyperhomocysteinemia

Interventions

Vitamin B 12

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMalabsorption Syndromes

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • YOGENDRA N KECHE, MD

    SMT KASHIBAI NAVALE MEDICAL COLLEGE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 27, 2015

First Posted

September 4, 2015

Study Start

October 1, 2010

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 15, 2018

Record last verified: 2018-03

Locations

IN(1)