Improving HbA1c Levels by Methylcobalamin Vitamin in Diabetic Volunteers

Al-Balqa Applied University

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Drug: Vitamin B12 0.5 MG/ACTUAT; Drug: Dapagliflozin 10mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT06241638

SREC-2022/783

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diabetic patient treated with Dapagliflozin

Exclusion criteria

• The levels of Vitamin B12 more than 200 ng/ml

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Dapagliflozin group

Active Comparator group

Description:

Dapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months

Treatment:

Drug: Dapagliflozin 10mg Tab

Vitamin B12 and Dapagliflozin group

Experimental group

Description:

Vitamin B12 and Dapagliflozin group received orally Vit. B12 supplements methylcobalamin 500 µg once daily with their usual anti-diabetic therapy Dapagliflozin 10 mg/daily for twelve months.

Treatment:

Drug: Dapagliflozin 10mg Tab

Drug: Vitamin B12 0.5 MG/ACTUAT