NL-OMON55126已完成不适用
Exercise to restore 24h rhythmicity in substrate metabolism of prediabetes subjects - Exercise to restore 24h rhythmicity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
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
- •Caucasian
- •Healthy (as determined by dependent physician based on medical questionnaire)
- •Age: 40-75
- •Overweight: BMI 25 - 35 kg/m2
- •Prediabetic 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
- •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
- •using OGIS120.
- •o HbA1c of 5.7-6.4%.
- •Regular sleeping time (normally 7 - 9h daily)
- •Stable dietary habits: no weight gain or loss > 3kg in the last three months
排除标准
- •Fasting plasma glucose >= 7.0 mmol/l
- •Haemoglobin < 7.8 mmol/l
- •In case of an abnormal ECG in rest: this will be discussed with the
- •responsible
- •medical doctor
- •Previously diagnosed with type 2 diabetes
- •Any medical condition and/or medication that might interfere with the
- •investigated parameters as judged by study physician.
- •Current alcohol consumption > 20 grams alcohol/day
- •Subjects who do not want to be informed about unexpected medical findings
- •during the screening /study, or do not wish that their physician is informed, 1
- •month prior to the screening visit
- •o Claustrophobia
- •Any contra-indication to the Equivital telemetric pill:
- •o Known or suspected obstructive disease of the gastrointestinal tract
- •o History of disorders or impairment of the gag reflex
- •o Previous gastrointestinal surgery
- •o Felinization of the esophagus
- •o Hypomotility disorders of the gastro-intestinal tract
- •Implanted electromedical device
- •Extreme early bird or extreme night person (score <=30 or >=70 on MEQ-SA
- •questionnaire, document F1-2)
- •Heavily varying sleep-wake rhythm
- •Nightshiftwork during last 3 months
- •Travel across > 1 time zone in the last 3 months
- •Engagement in exercise > 2 hours total per week
- •Significant food allergies/intolerance (seriously hampering study meals)
- •Participation in another biomedical study within 1 month before the first
- •study visit
- •Using > 400mg caffeine daily (more than 4 coffee or energy drink)
- •Any acute condition, exacerbation of chronic condition, or medical history
- •that would in the investigator*s opinion interfere with the study
研究者
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