Semaglutide's Effect on Renal Hemodynamics and Function in Patients With Type 2 Diabetes Mellitus and Nephropathy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age20-60
SponsorBispebjerg Hospital

About this trial

The goal of this double-blinded, placebo-controlled, randomized, crossover study is to examine the effect of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), on renal hemodynamics and function in patients with type 2 diabetes mellitus (T2DM) and moderate chronic kidney disease (CKD).

The study will determine the effects of semaglutide on:

* Renal arterial blood flow, regional renal perfusion, and oxygenation * Activity of the renin-angiotensin-aldosterone system (RAAS) * The glomerular filtration rate (GFR) * Sodium excretion in urine * Blood pressure and heart rate

Eligibility criteria

Qualifiers

Type 2 diabetes mellitus diagnosed through either HbA1c ≥6,5% but ≤8,5%, or <6,5% combined with either fasting plasma glucose ≥7,0 mmol/L or plasma glucose ≥11,1 mmol/L two hours after an oral glucose tolerance test (OGTT).

Estimated glomerular filtration rate (eGFR, CKD-EPI) between 30-60 mL/min/1.73m2

Urine Albumin:Creatinine ratio (UACR) ≥30mg/g

Stable RAAS blockade (ACE inhibitors or angiotensin II receptor blocker (ARB) with stable dosis for 4 weeks prior to screening)

Disqualifiers

Immunosuppressive therapy within 30 days of screening

Alcohol abuse

Medical treatment with glucocorticoids

Kidney transplantation

Trial design

Treatments tested in this trial

  • Semaglutide, 0.5 mg/mL
  • Placebo, Saline

Treatment groups

15 Participants
are divided into 2 treatment groups

Locations

1
Bispebjerg Hospital, Department of Clinical Physiology & Nuclear Medicine2400, CopenhagenCapital Region, Denmark

Sponsors and collaborators

Bispebjerg Hospital

Lead sponsor