Multicentre, prospective, randomised, blinded, placebo-controlled study to evaluate a novel medical device for long-lasting weight loss in overweight and obesity.

Praxis Dr. von Seck0 个研究点目标入组 21 人开始时间: 2015年7月28日最近更新: 2024年8月19日

研究概览

暂无简介。

•1.Age: 18 to 95 years
•2.Gender: Männer und Frauen
•3.BMI between 25 and 29.9 with concomitant obesity-related health disorders, an abdominal
•fat distribution pattern, diseases which are aggravated by obesity or a high degree of psychosocial pressure.
•4.BMI = 30 kg / m2
•5.Capacity to consent
•6.Signed consent form
•7.Desire to reduce weight
•8.Failure of a basic program (nutritional, exercise and behavioural therapy), i. e. less than 5% weight reductiom / 3 to 6 months or weight regain

•1.Weight reduction > 5% over the last months before inclusion into the study
•2.Individuals with denture, esp. worn with implants or pivot teeth
•3.Less than 10 teeth / joint, teeth with maximally mild to moderate paradontal Zähne pro Kiefer mit maximal leichter bis mittelschwerer paradontal defects
•4.Craniomandibular problems
•5.Wasting diseases
•6.Clinical diagnosis of an eating disorder
•7.Medication with substances influencing weight or appetite (i. e. steroids, psyotropic drugs, diuretics)
•8.Major surgical interventions durign the last 3 months
•9.Pregnancy or breastfeeding women
•10.Mental disorders or non-compliance
•11.Inability to take in meals on a regularly
•12.Incapacity to give informed consent
•13.Secondary causes of obesity, i.e. der Adipositas, wie hypothyrodism, cushings syndrome, hypogonadism, hypothalimic tumors, or metabolic decompensation in diabetes mellitus
•14.Newly diagnosed diabetes mellitus during the last 6 months before inclusion
•15.HbA1C > 9% in diabetics
•16.Uncontrolled arterial hypertension
•17.Initiation / change of medication for a chronic disease during the last 3 months before inclusion
•18.Participation in another clinical trial
•19.Participation in another weight reduction program in the last 3 months
•20.Unintended weight loss in the last 3 months
•21.Participation in another therapy program during the course of the study

发起方

Praxis Dr. von Seck