Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amsterdam UMC, location VUmc
With
Merck Sharp & Dohme LLC
University of Colorado, Denver
Age
35–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 Metformin, SU, insulin
All participants need to be on a stable dose of RAS inhibition
You may not be if
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:
* Acute coronary syndrome
* Chronic heart failure (New York Heart Association grade II-IV)
* 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
Clareo Health | DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study
