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

ConditionsDiabetes Mellitus, Type 2Kidney Disease, Chronic
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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Semaglutide, 0.5 mg/mL

    Drug

    1 subcutaneous injection on baseline day

  • Placebo, Saline

    Drug

    1 subcutaneous injection on baseline day

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: Randomized to start with Semaglutide intervention in study period 1Other 2 interventions
Group B: Randomized to start with Placebo intervention in study period 1Other 2 interventions

Trial outcomes

Primary outcomes

1

Total blood flow

Volume of blood per unit time, ml/min

Time frame
Measured during 30 minutes of MRI. One measurement will be done on each study day, a total of 4 measurements for each participant, over the span of the study (approximately 1 year).
2

Regional renal perfusion

volume of blood per unit time per unit tissue mass, ml/min/g

Time frame
Measured during 30 minutes of MRI. One measurement will be done on each study day, a total of 4 measurements for each participant, over the span of the study (approximately 1 year)

Secondary outcomes

1

Glomerular filtration rate

Volume per unit time, ml/min

Time frame
Measured with Tec99-DTPA clearance. One measurement will be done on each study day, a total of 4 measurements for each participant, over the span of the study (approximately 1 year)
2

Sodium excretion in urine

Concentration, mmol/l

Time frame
One measurement will be done on each intervention day, a total of 2 measurements for each participant, over the span of the study (approximately 1 year)
3

Activation of the renin angiotensin aldosterone system

Concentration, mmol/l

Time frame
Blood samples will be taken 3 times on each intervention day, a total of 6 measurements for each participant, over the span of the study (approximately 1 year)
4

Blood pressure

mmhg

Time frame
Measured continuously during a 60 minute period on each intervention day, a total of 2 measurements for each participant, over the span of the study (approximately 1 year)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bispebjerg Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: