NL-OMON54468招募中不适用
The effect of colchicine on Food-reLAted effort-based decision making in brain and behavIouR in overweight and obesity: the FLAIR-i study - FLAIR-i
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •General inclusion criteria:
- •BMI >= 30 kg/m2
- •Female sex
- •Age: 18-59 years
- •Low-grade inflammation, as defined by C-reactive protein (hsCRP) between 3.0
- •and 10.0 mg/L for BMI between 30-31 kg/m2, and hsCRP between 3.0 and 22.1 mg/L
- •for BMI > 31 kg/m2
- •In case of a hsCRP level above these thresholds, the measurement is repeated at
- •least 4 weeks after the first measurement (as part of the FLAIR-o study). For
- •this second measurement the following thresholds for exclusion are: hsCRP >
- •19.7 for BMI between 30-31 kg/m2 and hsCRP > 27.8 for BMI > 31 kg/m2
排除标准
- •Diagnosed with Diabetes Mellitus type I or II
- •Having been vaccinated in the 4 weeks preceding the first test session
- •Having had an infection characterized by a fever, or diagnosed by a medical
- •physician in the 4 weeks preceding the first test session
- •Gained or lost >2 points in BMI (kg/m2) over the last 6 months
- •Followed an energy restricting diet during the last 2 months
- •Having had bariatric surgery in the past 5 years
- •Habitual smoking, i.e. one or more cigarettes per day
- •Current or history of alcohol and/or drugs abuse (i.e. >14 units per week)
- •Pregnant, lactating or wishing to become pregnant in the period between the
- •screening and until 3 months after the last study visit (self-reported)
- •(History of) clinically significant psychiatric or neurological disorder
- •(History of) clinically significant metabolic, cardiovascular, renal,
- •endocrinological, autoimmune or chronic inflammatory disease
- •General medical conditions, such as sensorimotor handicaps, deafness,
- •blindness or colorblindness, as judged by the investigator
- •Regular use of anti-inflammatory, anti-diabetic, weight-loss, and
- •psychoactive medication
- •Regular use of CYP3A4 inhibitors, P-glycoprotein inhibitors, statins,
- •fibrates, ciclosporin, and digoxin, as a contraindication for colchicine
- •Renal impairment as evidenced by serum creatinine >150 µmol/l or eGFR
- •<50mL/min/1.73m2
- •Have moderate to severe hepatic disease
- •Contraindications for fMRI
研究者
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