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临床试验/NCT04283201
NCT04283201已完成2 期

Development, Implementation and Evaluation of the Effectiveness of Recommendations for the Prevention of Type 2 Diabetes in Ukraine

Komisarenko Institute of Endocrinology and Metobolism2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年2月20日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
New type 2 diabetes cases

研究概览

简要总结

Development, implementation and evaluation of the effectiveness of lifestyle recommendations for the prevention of type 2 diabetes in rural population of Ukraine

详细描述

An oral glucose tolerance test and anthropometric measurements were performed for 300 randomly selected rural residents of the Kyiv region of Ukraine. Persons from impaired glucose regulation category (impaired fasting glucose - IFG) was enrolled to diabetes prevention intervention study (T2DPUA).

Individuals in the IFG category received advice on limiting sugar intake (not more than 25 g per day), increasing physical activity (30 minutes daily). 30 persons from this category were additionally advised to consume insoluble dietary fiber 15 g per day (Vitacel wheat fiber) for 3 months, after which a repeat anthropometric and biochemical study. Objective control of physical activity and body composition is also provided.

研究设计

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

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persons with fasting blood glucose level >=6.1 mmol/l; persons aged 18-79 who signed an informed consent for the study.

排除标准

  • Known diabetes; acute infectious diseases; other serious diseases

结局指标

主要结局

New type 2 diabetes cases

时间窗: 3 month

fasting blood glucose level \>=6.1 mmol/l

次要结局

未报告次要终点

研究者

发起方
Komisarenko Institute of Endocrinology and Metobolism
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mykola Khalangot

Clinical Professor, Principal Investigator

Komisarenko Institute of Endocrinology and Metobolism

研究点 (2)

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Type 2 Diabetes Mellitus Prevention Ukraine | 临床试验