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临床试验/NL-OMON53883
NL-OMON53883尚未招募不适用

Timing exercise training as strategy to improve insulin sensitivity and substrate metabolism in men and woman with pre-diabetes - Timed Training Study

niversiteit Maastricht0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • Participants are able to provide signed and dated written informed consent
  • prior to any study specific procedures
  • Aged 40-75 years
  • Body mass index (BMI) >=25 kg/m2
  • Male, or postmenopausal (at least 1 year post cessation of menses) female
  • Have suitable veins for cannulation or repeated venepuncture
  • Pre-diabetes based on one or a combination of the following criteria:
  • o Impaired Glucose Tolerance (IGT): plasma glucose values >= 7.8 mmol/l and <=
  • 11.1 mmol/l 120 minutes after glucose drink consumption during OGTT in screening
  • o Impaired Fasting Glucose (IFG): Fasting plasma glucose >= 6.1 mmol/l and <= 6.9
  • o Insulin Resistance: glucose clearance rate <= 360 mL/kg/min, as determined
  • during the OGTT using OGIS120
  • o HbA1c of 5.7-6.4%

排除标准

  • Type 2 diabetes
  • Patients with active congestive heart failure and and/or severe renal and or
  • liver insufficiency
  • Uncontrolled hypertension
  • Any contra-indication for MRI scanning
  • Alcohol consumption of >3 servings per day for man and >2 serving per day for
  • Unstable body weight (weight gain or loss > 5kg in the last 3 months)
  • Previous enrolment in a clinical study with an investigational product during
  • the last 3 months or as judged by the Investigator which would possibly hamper
  • our study results
  • Medication use known to hamper subject*s safety during the study procedures
  • Subjects who do not want to be informed about unexpected medical findings
  • Men: Hb <8.0 mmol/L, Women: Hb <7.0 mmol/l
  • Heavily varying sleep-wake rhythm (i.e. night shift work and travels across
  • time zones).
  • Significant food allergies/intolerance (seriously hampering study meals)
  • Blood donation during or within 2 months prior to the study

研究者

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