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临床试验/NCT06725238
NCT06725238已完成不适用

The Interplay of Acute-to-Chronic Glycemic Ratio With Other Biomarkers in Diabetic Foot Ulcers: An Effect is Not Related to the Therapeutic Remedies

University of Diyala1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Acute-to-chronic glycemic ratio

研究概览

简要总结

Diabetic foot ulcers (DFUs) have resulted from peripheral arterial ischemia and peripheral neuropathy that are complicated with infections and amputation of the lower extremities. Uncontrolled glycemic status and significantly higher glycosylated hemoglobin (HbA1c) are associated with DFUs. This study aimed to assess the acute-to-chronic glycemic ratio (ACGR) in type 2 diabetes (T2D) with DFUs and compare it with those without DFUs, considering the relationships of this ratio with other indices that characterized the pathogenesis of T2D. This cross-sectional study was conducted on T2D with DFUs and non-DFUs. The primary outcome is ACGR. The secondary outcomes are indices related to the anthropometric, metabolic, and hematological variables.

详细描述

DFUs are a macrovascular complication of diabetes mellitus resulting from peripheral artery disease and peripheral neuropathy that commonly affects the lower extremities. The DFUs are usually classified and scored according to the clinical findings. The ACGR is computed by dividing the acute (or current, or on admission in hospital) plasma glucose level by the chronic plasma glucose level calculated using the current (or on admission) HbA1c value.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 Diabetes Clinical and laboratory diagnosis of diabetic foot ulcers Treatment with oral anti-diabetes +/- insulin

排除标准

  • History of recent systemic infections Alcohol consumption Surgical procedures within 4 weeks Pregnant or breast-feeding women; Terminal illnesses.

结局指标

主要结局

Acute-to-chronic glycemic ratio

时间窗: The measurement is done at the time of recruitment

The glycemic index represents the current or acute level of fasting plasma glucose and the HbA1c, which indicates the chronic glycemic status, is elevated in DFUs. The chronic plasma glucose level could be determined by using the equation of 28.7 × HbA1c (%) - 46.7.

次要结局

  • Leucocyte-glucose index(at the time of recruitment)

研究者

发起方
University of Diyala
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwan Salih Mohamad Al-Nimer

Professor of Clinical Pharmacology and Therapeutics

University of Diyala

研究点 (1)

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