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DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study | Clinical Trials | Clareo Health

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DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study

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

NCT05727579•Amsterdam UMC, location VUmc

View on ClinicalTrials.gov

Summary

SGLT2 inhibitors such as ertugliflozin improve blood pressure and kidney outcomes in people living with diabetes through incompletely understood mechanisms, however, not all patients treated with SGLT2 inhibition have improved outcomes. Changes in kidney sodium handling is among the mechanisms by which SGLT2 inhibition may reduce blood pressure and drive beneficial kidney outcomes. This process is heavily dependent on daily sodium intake by patients receiving SGLT2 inhibitor treatment. In this study, the effect of daily sodium intake on SGLT2-inhibitor induced physiological effect is studied, including blood pressure regulation and kidney physiology.

Eligibility

Age

35 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+2 more criteria

Exclusion Criteria

•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)
+8 more criteria

Key Dates

Start Date

June 1, 2023

Primary Completion Date

September 1, 2024

Completion Date

March 1, 2025

Last Updated

May 1, 2023

Enrollment

ESTIMATED participants

Conditions

Diabetes MellitusDiabetic Kidney DiseaseHypertension

Interventions

Salt-Diet and/or Ertugliflozin

OTHER

Contacts

Daniel van Raalte, MD PhD

CONTACT

+31204440534 d.vanraalte@amsterdamumc.nl

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study

Inclusion Criteria

Exclusion Criteria

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