Improving HbA1c Levels by Methylcobalamin Vitamin in Diabetic Volunteers

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Dapagliflozin 10mg Tab; Drug: Vitamin B12 0.5 MG/ACTUAT

• Registration Number: NCT06241638
• Lead Sponsor: Al-Balqa Applied University

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.

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2024-01
• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-26
• Last Update Submitted: 2024-01-26
• Study First Posted: 2024-02-05
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Diabetic patient treated with Dapagliflozin

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin group	Dapagliflozin 10mg Tab	Dapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months
Vitamin B12 and Dapagliflozin group	Vitamin B12 0.5 MG/ACTUAT	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.
Vitamin B12 and Dapagliflozin group	Dapagliflozin 10mg Tab	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.

Primary Outcome Measures

Name	Time	Method
HbA1c in the two groups	One year	The diabetic status in the two groups was evaluated by measuring the HbA1c levels

Trial Locations

Locations (1)

Walid Aburayyan; 🇯🇴 Salt, Jordan