Diabetes Mellitus
Conditions
Brief summary
The current study was conducted to evaluate the prognostic implications of vitamin B12 admission on BMI and HbA1c levels in type 2 diabetic patients treated with Dapagliflozin as a routine medication.
Detailed description
Eighty diabetic patients were enrolled in this study; 37 females and 43 males with inclusion criteria of vitamin B12 levels less than 233 ng/ml. The participants were divided into two groups, the Dapagliflozin group (active comparator group) received only the diabetic-controlling drug Dapagliflozin 10 mg/daily orally for twelve months, whereas, vitamin B12 and Dapagliflozin group (Experimental group) received Vit. B12 supplements as methylcobalamin 500 µg orally once daily with Dapagliflozin 10 mg/daily orally for twelve months. Glycemic control was measured by monitoring levels of HbA1c and Vitamin B12 in the participant's blood four times at time intervals of three months during the study period. Additionally, the weight measurements were recorded during the study period at time intervals of three months and BMI was calculated. The data obtained was treated by statistical analysis using SPSS software (version 20) for the significant correlation of the independent variables of the study groups after vitamin B12 supplementation.
Interventions
DRUGVitamin B12 0.5 MG/ACTUAT
The investigators measured the blood levels of Vitamin B12 and HbA1c as well as the BMI in two study groups; The Experimental group: Vitamin B12 and Dapagliflozin group and Active Comparator group: Dapagliflozin group. The Dapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months, whereas, the Vitamin B12 and Dapagliflozin group received Vit. B12 supplements methylcobalamin 500 µg once daily orally with the anti-diabetic therapy Dapagliflozin 10 mg/daily orally for twelve months.
DRUGDapagliflozin 10mg Tab
The investigators measured the blood levels of Vitamin B12 and HbA1c as well as the BMI in two study groups; The Experimental group: Vitamin B12 and Dapagliflozin group and Active Comparator group: Dapagliflozin group. The Dapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months, whereas, the Vitamin B12 and Dapagliflozin group received Vit. B12 supplements methylcobalamin 500 µg once daily orally with the anti-diabetic therapy Dapagliflozin 10 mg/daily orally for twelve months.
Sponsors
Al-Balqa Applied University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Diabetic patient treated with Dapagliflozin
Exclusion criteria
* The levels of Vitamin B12 more than 200 ng/ml
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c in the two groups | One year | The diabetic status in the two groups was evaluated by measuring the HbA1c levels |
Countries
Jordan
Outcome results
None listed