EUCTR2020-006127-34-AT进行中（未招募）1 期
Empagliflozin as potential treatment option for postprandial hyperinsulinemic hypoglycaemia after bariatric surgery – a pilot study - n/a
Verein zur Förderung der Wissenschaft und Forschung an der 1.Med. Abteilung der Krankenanstalt Rudolfstiftung0 个研究点目标入组 60 人开始时间: 2021年8月9日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •>= 18 years, <=65 years, no diagnosis of type 2 diabetes mellitus, Time of bariatric surgery > 1 year, No reported hypoglycemic episodes before bariatric surgery, Symptoms of PHH after bariatric surgery
- •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
排除标准
- •diabetes mellitus type 1, type 2 or HbA1c = 6.5% or use anti-diabetic drugs or insulin, Use of any drug to treat PHH in the last four weeks (acarbose etc.), Have a current infection, anamnestic necrotising fasciitis, Follow a ketogenic diet, impaired renal function with a eGFR = 60 ml/min/m², recurrent urinary tract infections (= 2 episodes during the last year), pyelonephritis (=1 episode during the last 5 years), urosepsis (=1 episode during the last 5 years), Known or suspected hypersensitivity to trial product(s) or related products, Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method, Have diagnosed insulinoma, Had reoperation or revision of bariatric surgery , severe gastroparesis, BMI = 18.5 kg/m², severe cardiovascular disease with any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 90 days prior to the day of screening, Subjects presently classified as being in New York Heart Association Class IV, Have acute or chronic hepatitis, signs or symptoms of any other liver disease, or an alanine transaminase (ALT) level =3.0 above the upper limit of normal (ULN) for the reference range, as determined by the central laboratory, Have a history of an active or untreated malignancy, or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years, Have a history of any other condition (such as known drug or alcohol abuse or psychiatric disorder) that, in the opinion of the investigator, may preclude the patient from following and completing the protocol, Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study, Have participated, within the last 30 days in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer), should have passed
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