DRKS00003349已完成2 期
FTO-genotype dependent weight reduction under treatment with bromocriptine in obese patients - GAB-FTO
niversität zu Köln0 个研究点目标入组 47 人开始时间: 2012年10月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
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 one（—）
- 性别
- All
入选标准
- •1.BMI = 30 kg/m2
- •2.Age = 18 years
- •3.Existence of written informed consent
排除标准
- •1.Known intolerance to bromocriptine or other components oft he IMP
- •2.Diabetes mellitus type 1 and type 2 (excluded by measurement of HbA1c at the screening visit, exclusion with HbA1c > 6,5%)
- •3.Hypo- or hyperthyroidism (excluded by measurement of TSH, fT3 and fT4)
- •4.Pregnancy or lactation
- •5.Known uncontrolled arterial hypertension (systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg; both under antihypertensive treatment)
- •6.Known coronary heart disease
- •7.Known peripheral artery occlusive disease (PAOD)
- •8.Known existence of one of the following hepatic diseases: acute or chronic viral hepatitis, cirrhosis oft he liver
- •9.Known existence of renal insufficiency, according to a glomerular filtration rate (GFR) = 59 ml/min (calculation according to the MDRD formula)
- •10.Known existence of Parkinson’s Disease
- •11.Known existence or history of one of the following psychiatric diseases: major depression, mania, anxiety disorder, obsessive compulsive disorder, schizophrenia, psychosis, addiction
- •12.Known existence of the following pituitary diseases: hormone secreting microadenoma of the pituitary, pituitary macroadenoma, hypophysitis
- •13.Treatment with bromocritine in the past 12 month
- •14.Known existence of a neurodegenerative disorder
- •15.Known existence of a gastric or intestinal ulcer
- •16.Known existence of a malignant disease in the past 5 years
- •17.Known existence of a congestive heart disease (NYHA III or IV)
- •18.Excess of specific thresholds of laboratory parameters listed in the study protocol
- •19.Comedication with drugs listed in table 5 (study protocol 4.3.2)
- •20.Cardiac pacemaker
- •21.Participation in another interventional study and intake of another investigational drug in the past 21 days
- •22.Persons who are in a relationship of dependency or who are employed by the sponsor or one of the investigators of the study
- •23.Accommodation in an institution with court order or official order
- •24.Non-existence of reliable contraception. Reliable contraception is defined as methods with a Pearl-Index below 1%:
- •a.Oral hormonal contraception (pill”)
- •b.Dermal hormonal contraception
- •c.Vaginal hormonal contraception (NuvaRing®)
- •d. contraception pflaster
- •e.Long active injectable contraception
- •f.Progesterone-releasing implant (Implanon®)
- •g.Tubal ligation (female sterilisation)
- •h.Hormone-releasing intrauterine device (coil”)
研究者
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