DRKS00008922招募中未知
Multicentre, prospective, randomised, double-blind, placebo-controlled study to evaluate the mechanism of a novel medical device for long-lasting weight loss in overweight and obesity.
Praxis Dr. med. von Seck0 个研究点目标入组 15 人开始时间: 2015年7月29日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 95 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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