Improving HbA1c Levels by Methylcobalamin Vitamin in Diabetic Volunteers

Diabetes Mellitus Clinical Trial

Official title:

Improving HbA1c Levels by Methylcobalamin Vitamin in Diabetic Volunteers, Combined With Dapagliflozin as Type Two Diabetes Mellitus Routine Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06241638
• Other study ID #: SREC-2022/783
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2024
• Source: Al-Balqa Applied University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diabetic patient treated with Dapagliflozin

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Vitamin 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.
• Dapagliflozin 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.

Locations

Country	Name	City	State
Jordan	Walid Aburayyan	Salt

Sponsors (1)

Lead Sponsor	Collaborator
Al-Balqa Applied University

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c in the two groups	The diabetic status in the two groups was evaluated by measuring the HbA1c levels	One year