EUCTR2019-002262-12-ES进行中（未招募）1 期
Effect of dapagliflozin on glomerular hyperfiltration in nondiabeticobese patients with or without treatment with ACEIs.Pilot clinical trial of efficacy, low level of intervention, unicentric,randomized and simple blind. - DAPA-OB
Hospital Universitari Germans Trias i Pujol0 个研究点目标入组 60 人开始时间: 2021年9月1日最近更新:
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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
- •1) Age =18 and =70 years
- •2) Diagnosis of obesity (body mass index =30 Kg/m²)
- •3) Diagnosis of measured glomerular hyperfiltration (mGFR =
- •120mL/min) by clearance of iohexol.
- •4) Understanding and accepting the clinical trial and willing to sign
- •informed consent
- •5) Twenty of the 60 subjects included must be on a stable dose of
- •angiotensin converting enzyme inhibitors (ACEI) for at least 4 weeks
- •prior to randomization.
- •6) Women of Child-Bearing Potential (WOCBP: women who have
- •experienced menarche and who have not undergone successful surgical
- •sterilization -hysterectomy, bilateral tubal ligation, or bilateral
- •oophorectomy- or who are not post-menopausal): must be using an
- •acceptable method of contraception (barrier, hormonal or intra uterine
- •device) to avoid pregnancy throughout the study and for up to 4 weeks
- •after the last dose of study drug in such a manner that the risk of
- •pregnancy is minimized.ç7) WOCBP must have a negative serum or urine pregnancy test result
- •within 0 to 72 hours before the first dose of study drug.
- •8) Women must not be breast-feeding.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1) Not complying inclusion criteria.
- •2) Diagnosis of type 1 or type 2 Diabetes Mellitus.
- •3) History of severe hypersensitivity or contraindications to
- •dapagliflozin.
- •4) Lactose intolerance or glucose-galactasa malabsorption.
- •5) Treatment a month prior clinical trial beginning of any oral
- •antidiabetic.
- •6) Autosomal dominant polycystic kidney disease or autosomal recessive
- •polycystic kidney disease, lupus nephritis, or ANCA-associated vasculitis.
- •7) Receiving cytotoxic therapy, immunosuppressive therapy, or other
- •immunotherapy for primary or secondary renal disease within 6 months
- •prior to enrolment.
- •8) History of organ transplantation.
- •9) History of New York Heart Association (NYHA) class IV of cardiac
- •insufficiency.
- •10) Miocardial infarction, unstable angina, stroke or transient ischemic
- •attack within 12 weeks prior to enrolment.
- •11) Any medication, surgical or medical condition which might
- •significantly alter the absorption, distribution, metabolism, or excretion
- •of medications including, but not limited to any of the following:
- •- History of active inflammatory bowel disease within the last six
- •- Major gastrointestinal tract surgery such as gastrectomy,
- •gastroenterostomy, or bowel resection;
- •- Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding
- •within last six months;
- •- Pancreatic injury or pancreatitis within the last six months;
- •- Evidence of hepatic disease as determined by any one of the following:
- •ALT or AST values exceeding 3x ULN at the screening visit, a history of
- •hepatic encephalopathy, a history of esophageal varices, or a history of
- •portocaval shunt.
- •12) History of drug or alcohol abuse within the 12 months prior to
- •dosing, or evidence of such abuse as indicated by the laboratory assays
- •conducted during the screening.
- •13) Active malignancy aside from treated squamous cell or basal cell
- •carcinoma of the skin.
- •14) History of > 2 urinary infections within the last year.
- •15) Pregnancy or breastfeeding.
- •16) Participation in any clinical investigation within 3 months prior to
- •initial dosing.
- •17) History of noncompliance to medical regimens or unwillingness to
- •comply with the study protocol.
- •18) Any surgical or medical condition, which in the opinion of the
- •investigator, may place the patient at higher risk from his/her
- •participation in the study, or is likely to prevent the patient from
- •complying with the requirements of the study or completing the study.
- •19) Treatment with antidiabetic drugs, surgery, aggressive diet regimen
- •or significant increase of physical exercise leading to unstable body
- •19) WOCBP who are unwilling or unable to use an acceptable method to
- •avoid pregnancy for the entire study period and up to 4 weeks after the
- •last dose of study drug.
- 另有 5 项未显示
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