DiEtary Sodium Intake effects on ertugliflozin-induced changes in GFR, reNal oxygenation and systemic hemodynamics: the DESIGN study, a randomized, placebo-controlled, cross-over study with ertugliflozin in people with type 2 diabetes.

Amsterdam UMC1 个研究点分布在 1 个国家目标入组 17 人开始时间: 2024年10月3日最近更新: 2024年10月3日

试验速览

阶段: 4 期
状态: 招募中
发起方
入组人数: 17
试验地点: 1
主要终点: To investigate the modifying effects of WHO-recommended sodium intake (90 mmol per day) vs. high sodium intake (targeted at 250 mmol per day) on the effect of ertugliflozin 15 mg daily, versus placebo, on 24-hour blood pressure in overweight/obese adults with type 2 diabetes.

研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To investigate the modifying effects of WHO-recommended sodium intake (90 mmol per day) vs. high sodium intake (targeted at 250 mmol per day) on the effect of ertugliflozin 15 mg daily, versus placebo, on 24-hour blood pressure in overweight/obese adults with type 2 diabetes.

入排标准

年龄范围: 65 years 至 65+ years（65+ Years）
接受健康志愿者: 否

入选标准

•Adults with previously diagnosed T2DM according to American Diabetes Association (ADA) criteria • HbA1c 6.5-10% • Age 35-80 years of age • Overweight or obese with BMI: >25 kg/m2 • We will make every effort to enrol participants of all races/ethnicities.” • Both sexes (females must be post-menopausal; no menses >1 year; in case of doubt, Follicle-Stimulating Hormone (FSH) will be determined with cut-off defined as >31 U/L) • Ability to provide signed and dated, written informed consent prior to any study procedures • Estimated GFR 60-90 ml/min/1.73m2 by CKD-EPI matching the eGFR range of most participants in VERTIS-CV • Sodium intake at baseline < 200 mmol/day • UACR < 30 mg/mmol • All participants need to be on a stable dose of diabetes medication, including Metforming, SU, DPP4-inhibitors, or insulin. • All participants need to be on a stable dose of RAS blocker

排除标准

•History of unstable or rapidly progressing renal disease • Estimated GFR <60 mL/min/1.73m2 or eGFR > 90 mL/min/1.73m2 determined by CKD-EPI • UACR > 30 mg/mmol • Current/chronic use of the following medication: SGLT2 inhibitors, TZD, GLP-1RA, glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs). Subjects on diuretics will only be excluded when these drugs cannot be stopped for the duration of the study. • Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e. sports injury, headache or back ache). However, no such drug can be taken within a timeframe of 2 weeks prior to renal testing • History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and/or hospitalization) within 1 month prior to the Screening visit. • Current urinary tract infection and active nephritis • Recent (<6 months) history of cardiovascular disease, including: o Acute coronary syndrome o Chronic heart failure (New York Heart Association grade II-IV) o Stroke or transient ischemic neurologic disorder • Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN • History of or actual malignancy (except basal cell carcinoma) • History of or actual severe mental disease • Substance abuse (alcohol: defined as >4 units/day) • Allergy to any of the agents used in the study • Individuals who are investigator site personnel, directly affiliated with the study, or are immediate (spouse, parent, child, or sibling, whether biological or legally adopted) family of investigator site personnel directly affiliated with the study • Inability to understand the study protocol or give informed consent

结局指标

主要结局

次要结局

GFR by iohexol clearance  Hematocrit  Office blood pressure  Kidney oxygenation  Parameters of intra kidney hemodynamic function including ERPF by p-aminohippurate (PAH) clearance and renal vascular resistance  Body anthropometrics  Fasting plasma glucose  Albumin excretion rate (24 hour)  24-hr urinary glucose excretion  Urinary and plasma biomarkers

研究者

发起方

Amsterdam UMC

申办方类型

Hospital/Clinic/Other health care facility

责任方

Principal Investigator

主要研究者

D.H. van Raalte

Scientific

Amsterdam UMC

研究点 (1)

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