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

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If you choose to participate, you will take the study medication, ertugliflozin, or placebo over 4 so-called treatment blocks of 20 days each. You will be recommended foods based on a sodium-controlled diet for approximately 23 weeks. There will be 5 study visits total over 23 weeks, which will involve the study procedures listed below. Visit 1: Screening visit (~2 hrs): Obtain consent Review medications and medical history Physical exam, height, weight, and vital signs Collect blood and urine samples for lab tests Discuss study diet recommendations Electrocardiogram (ECG) Provide 24-hour urine and blood pressure cuff Treatment period: Take one pill of ertugliflozin or placebo per day for 10 days (for each of the 4 treatment blocks).. Each of the 4 treatment blocks is 20 days. The first 10 days is a strict sodium diet, then the last 10 days is the same sodium diet plus the daily study medication. Long visits (4 visits total, ~5 hours each) Collect blood & urine samples for lab tests Renal Clearance Test Kidney MRI Medical history and vitals In between visits: Collect 24-hour urines (5 times) Wear blood pressure monitoring device (5 times) Telephone calls (4 times) Total Compensation of the DESIGN Study is $950.00




You are between 35 and 80 years old You have type 2 diabetes and are overweight or obese (BMI: >25 kg/m2)


Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Jessica Kendrick

Jessica Kendrick

Study ID

Protocol Number: 22-0224

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