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
NCT ID: NCT06983054
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
34 participants
INTERVENTIONAL
2023-07-25
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Low salt diet with SGLT2i
10 days of SGLT2i treatment during 20 days of low salt diet
ertugliflozine
SGLT2i versus placebo
low salt diet
comparing low salt versus high salt diet
Low salt diet with placebo
10 days of placebo during 20 days of low salt diet
low salt diet
comparing low salt versus high salt diet
placebo
placebo tablet
High salt diet with SGLT2i
10 days of SGTL2i during 20 days of high salt diet.
ertugliflozine
SGLT2i versus placebo
high salt diet
high salt diet
High salt diet with placebo
10 days of placebo during 20 days of high salt diet.
placebo
placebo tablet
high salt diet
high salt diet
Interventions
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ertugliflozine
SGLT2i versus placebo
low salt diet
comparing low salt versus high salt diet
placebo
placebo tablet
high salt diet
high salt diet
Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
* 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:
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Children's Hospital Colorado
OTHER
Amsterdam UMC, location VUmc
OTHER
Responsible Party
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Daniel van Raalte
Prof. Dr.
Locations
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Childrens hospital colorado
Denver, Colorado, United States
Amsterdam UMC
Amsterdam, , Netherlands
Countries
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Facility Contacts
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Other Identifiers
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2023-510257-42-01
Identifier Type: CTIS
Identifier Source: secondary_id
2021-005474-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NL80772.029.22
Identifier Type: -
Identifier Source: org_study_id
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