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

Donders Institute for Brain, Cognition and Behaviour, Radboud University0 个研究点目标入组 60 人开始时间: 2022年1月19日最近更新: 2024年4月22日

适应症

试验速览

暂无简介。

•General inclusion criteria:
•BMI = 30 kg/m2
•Female sex
•Age: 18-59 years
•Right-handed
•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 after at least 4 weeks (as part of the FLAIR-o study, NL77503.091.21). For this second measurement the thresholds for inclusion are: hsCRP 3.0-19.7 for BMI between 30-31 kg/m2 and hsCRP 3.0-27.8 for BMI > 31 kg/m2.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Diagnosed with Diabetes Mellitus type I or II
•Having been vaccinated in the 4 weeks preceding the first test session
•Gained or lost >5 kg of body weight over the last 6 months
•Followed an energy restricting diet during the last 2 months
•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, anti-histamine 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

发起方

Donders Institute for Brain, Cognition and Behaviour, Radboud University