EUCTR2015-000197-35-IT进行中(未招募)不适用
insulin resistance, obesity and gastrointestinal bacteria - HR-HP-14-01
AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI0 个研究点目标入组 100 人开始时间: 2016年3月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •proven hyper-insulinismo (using OGTT)
- •BMI> 24.9 kg / m2 and <39.9 kg / m2
- •Age = 18 years and = 65
- •Informed consent 1 [ for the immunoassay on stool]
- •Informed consent 2 [for Visit1 enrollment]
- •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 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who have already performed a therapy for the eradication of Helicobacter pylori, including proton pump inhibitors, preparations of bismuth, prokinetic or antibiotics in the two previous months;
- •Patients who make use of drugs including anti-inflammatory and / or aspirin, glucose and lipid-lowering agents; alcohol addiction; previous gastric surgery; decompensated congestive heart failure; liver cirrhosis; chronic renal failure; diagnosis of cancer; pregnancy; systemic or local infections
- •Women of childbearing potential not using contraception and breastfeeding women;
- •Known or suspected hypersensitivity to the drug or drug class in the studio;
- •Patients with serious medical conditions that, in the opinion of the investigator, contraindicate the patient's participation in the study;
- •Use of experimental drugs in the last three months prior to study entry.
研究者
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