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临床试验/NCT06241638
NCT06241638已完成不适用

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

Al-Balqa Applied University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
HbA1c in the two groups

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diabetic patient treated with Dapagliflozin

排除标准

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

研究组 & 干预措施

Dapagliflozin group

Active Comparator

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

干预措施: Dapagliflozin 10mg Tab (Drug)

Vitamin B12 and Dapagliflozin group

Experimental

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.

干预措施: Vitamin B12 0.5 MG/ACTUAT (Drug)

Vitamin B12 and Dapagliflozin group

Experimental

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.

干预措施: Dapagliflozin 10mg Tab (Drug)

结局指标

主要结局

HbA1c in the two groups

时间窗: One year

The diabetic status in the two groups was evaluated by measuring the HbA1c levels

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Walid Salem Aburayyan

Associate Professor

Al-Balqa Applied University

研究点 (1)

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