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临床试验/NCT06533618
NCT06533618已完成不适用

Characterization of the "Transfusion-dependent Prediabetes" Using Continuous Glucose Monitoring: the Hemoglycare Study

University of Campania Luigi Vanvitelli1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2023年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
Number of participants with pre diabetes in Transfusion dependent patients

研究概览

简要总结

Dysglycemia is a frequent finding in transfusion-dependent thalassemia (TDT). The oral glucose tolerance test (OGTT) remains the only validated screening test, but the procedure is complex and time-consuming. Continuous glucose monitoring (CGM) systems are simple to use, and could have a role in the diabetes mellitus diagnosis. This study involved 39 participants (19 cases and 20 healthy controls) using CGM for the analysis of the glucose metrics. Participants resulted negative for diabetes mellitus screening tests. Patients' clinical data were compared with glucose metrics.

详细描述

The selection of patients took place randomly among adult patients suffering from transfusion-dependent thalassemia (TDT) belonging to the Pediatric Hematology and Oncology Unit of the AOU University of Campania "L. Vanvitelli". Patients had a history of at least 10 years of therapy with red blood cell transfusions (transfusion frequency less than one months) and iron chelation therapy. Cases tested negative for diabetes mellitus screening tests (fasting glycemia, OGTT).

Some healthy volunteers were also recruited among medical resident and doctors. Major eligibility criteria for the volunteers were: caucasian; age ≥18 years; body mass index <25.0 kg/m2; no chronic illness or medications that might affect glucose metabolism; fasting glycemia<100 mg/dl; HbA1c <5.7% (39 mmol/mol); no positive islet autoantibodies; HOMA-IR <2.5. Female participants pregnant at the time of study enrollment were not eligible.

All procedures performed in this study were approved by the Institutional Research Committee of the University of Campania "Luigi Vanvitelli". All participants have provided written consent.

Demographic and Clinical characteristics A brief schedule was specifically designed and completed by clinicians (diabetologists or hematologists) to record demographic and clinical data, including age, gender, height, weight, duration of illness, and other medical conditions (family history of diabetes, endocrine disorders, cigarette smoking habit). Finally, the HOMA-IR was calculated as a parameter for evaluating insulin resistance. Possible missing data was obtained by reviewing medical charts

Study design

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •They were affected by transfusion-dependent thalassemia (TDT)
  • •They had a history of at least 10 years of therapy with red blood cell transfusions (transfusion frequency less than one months) and iron chelation therapy
  • •They tested negative for diabetes mellitus screening tests (fasting glycemia, OGTT).

排除标准

  • •Pregnancy

研究组 & 干预措施

Thalassemic patients

Experimental

Patient affected by TDD

干预措施: Continuous glucose monitoring system (Diagnostic Test)

Healthy controls

Experimental

caucasian; age ≥18 years; body mass index <25.0 kg/m2; no chronic illness or medications that might affect glucose metabolism; fasting glycemia<100 mg/dl; HbA1c <5.7% (39 mmol/mol); no positive islet autoantibodies; HOMA-IR <2.5

干预措施: Continuous glucose monitoring system (Diagnostic Test)

Euglycemic thalassemic patients

Experimental

Glucose metrics characteristic: (Time above range≥140 mg/dl: ≤ 6%)

干预措施: Continuous glucose monitoring system (Diagnostic Test)

Hyperglicemic thalassemic patients

Experimental

Glucose metrics characteristic: (Time above range≥140 mg/dl: >6%)

干预措施: Continuous glucose monitoring system (Diagnostic Test)

结局指标

主要结局

Number of participants with pre diabetes in Transfusion dependent patients

时间窗: Seven days

Transfusion dependent patients were studied using a continuous glucose monitoring system with the aim to show condition of dysglicemia (prediabetes)

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

Angela Zanfardino

Medical Doctor

University of Campania Luigi Vanvitelli

研究点 (1)

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