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临床试验/NCT06603480
NCT06603480已完成不适用

Effects of Exercise and Metformin on Methylglyoxal Levels in Prediabetic Individuals

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2021年4月8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
96
试验地点
2
主要终点
MGO

研究概览

简要总结

The aim of this study is to compare the effects of exercise, standard lifestyle changes and metformin on MGO in prediabetic individuals.

详细描述

There is no comparative study in the literature evaluating the effects of exercise and metformin on MGO in prediabetic patients. The aim of this study is to compare the effects of exercise, standard lifestyle changes and metformin on MGO in prediabetic individuals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who were newly diagnosed with prediabetes by Oral Glucose Tolerance Test (OGTT) and/or HbA1C,
  • who were assessed as physically inactive (Level 1) according to the International Physical Activity Questionnaire
  • who had sufficient motivation to participate in the exercise program (assessed by one-on-one interviews conducted by the researchers),
  • who were deemed suitable to participate in the exercise program after a cardiac examination by a cardiologist (with resting electrocardiogram and questioning of cardiac symptoms, and advanced tests such as exercise electrocardiogram test when necessary),
  • who had the same weight (±2.5 kg) for 6 months before participating in the study.

排除标准

  • having a serious medical condition that would prevent the person from participating in the exercise study (e.g. advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.),
  • having used metformin for 6 months before the study, having cardiovascular disease,
  • heart failure, cancer, having a BMI <19 kg/m2, receiving hormone replacement therapy,
  • having a life expectancy of less than 1 year, being HIV positive, substance use,
  • functional dependence, having an orthopedic disease that prevents physical activity,
  • having cognitive impairment and other diseases that would affect the study results (respiratory diseases, muscle diseases, non-alcoholic fatty liver disease, etc.),
  • using medications or supplements that would affect the study results.

结局指标

主要结局

MGO

时间窗: 1 week

Methylgloxal level

次要结局

未报告次要终点

研究者

发起方
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
申办方类型
Other
责任方
Sponsor

研究点 (2)

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