NL-OMON46463已完成不适用
Day-night rhythm in muscle metabolism of prediabetic subjects - Day-night rhythm in muscle metabolism of prediabetics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
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 screening.
- •o Impaired Fasting Glucose (IFG): Fasting plasma glucose * 6.1 mmol/l and * 6.9 mmol/l.
- •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
- •* Use of anticoagulants
- •* Fasting plasma glucose * 7.0 mmol/l
- •* Haemoglobin < 7.8 mmol/l
- •* 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
- •* Any contra-indication to Magnetic Resonance Imaging (MRI) scanning:
- •o Any implant or prosthesis that is contra-indicated for MRI (e.g. cardiac pacemaker, defibrillator, neural stimulator and other)
- •o Metal containing foreign bodies in the eye or brain
- •o Any other metal containing objects contra-indicated for MRI scanning (e.g. certain prosthetic limbs, certain tattoos or certain permanent eyeliner*)
- •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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