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
- Conditions
- Type 2 Diabetes100126531002914910057166
- Registration Number
- NL-OMON53765
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 22
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.
• 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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate the modifying effects of WHO-recommended sodium intake (90 mmol<br /><br>per day) vs. high sodium intake (targeted at 250 mmol per day) on the effect of<br /><br>ertugliflozin 15 mg daily, versus placebo, on 24-hour blood pressure in<br /><br>overweight/obese adults with type 2 diabetes.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To investigate the efficacy of ertugliflozin 15 mg daily, versus placebo, in<br /><br>overweight/obese adults with type 2 diabetes to reduce the hypertensive effects<br /><br>of a high-sodium diet (250 mmol per day) versus 24-hour blood pressure<br /><br>measurement during participant*s normal diet (170 mmol/per day) obtained at<br /><br>screening visit.</p><br>