NL-OMON53765招募中4 期
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 - DESIG
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •Adults with previously diagnosed T2DM according to American Diabetes
- •Association (ADA) criteria
- •HbA1c 6.5-10%
- •Age 18 - 85 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 Metformin, SU, DPP4-inhibitors, or insulin.
- •Participants suffering from hypertension need to be on a stable dose of RAS
- •inhibitors. In case RAS inhibition is not tolerated, the participant should to
- •be on a stable dose of other antihypertensive treatment.
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
- •UACR > 30 mg/mmol
- •Current/chronic use of the following medication: SGLT2 inhibitors, TZD,
- •GLP-1RA, glucocorticoids, immune suppressants, antimicrobial agents,
- •chemotherapeutics Participants should be on a stable dose of 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
- •Active malignancy. History of malignancy is allowed unless the participant
- •still has active treatment other than hormonal therapy.
- •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
研究者
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