Effects of sodium intake on kidney function changes with ertugliflozin in type 2 diabetes
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
This study is testing how different amounts of salt in the diet affect kidney function in people with type 2 diabetes who are taking the medication ertugliflozin.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Locations | 2 sites (Denver, Colorado and 1 other locations) |
| Trial ID | NCT06983054 on ClinicalTrials.gov |
What this trial studies
This study investigates how dietary sodium intake influences the effects of ertugliflozin, a medication used to treat type 2 diabetes, on kidney function and systemic blood flow. It is a randomized, placebo-controlled, cross-over study that will assess participants' responses to different sodium diets while on ertugliflozin. The goal is to understand the mechanisms behind the protective effects of SGLT2 inhibitors and how dietary factors may modify these effects. The findings could lead to optimized dietary recommendations for patients taking this medication.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with type 2 diabetes, a BMI over 25, and stable diabetes medication.
Not a fit: Patients with severe kidney impairment or those not meeting the sodium intake criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment strategies for patients with type 2 diabetes, potentially improving kidney health and overall outcomes.
How similar studies have performed: Previous studies have shown promising results with SGLT2 inhibitors, but this specific dietary approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * History of unstable or rapidly progressing renal disease NL80772.029.22 / DC2022ERTU DESIGN Protocol DESIGN, Study NO. 2022.0737 Version 5.0dd22-02-2024 14 of 45 * 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
Where this trial is running
Denver, Colorado and 1 other locations
- Childrens hospital colorado — Denver, Colorado, United States (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.