Status:
NOT_YET_RECRUITING
Semaglutide's Effect on Renal Hemodynamics and Function in Patients With Type 2 Diabetes Mellitus and Nephropathy
Lead Sponsor:
Bispebjerg Hospital
Conditions:
Diabetes Mellitus, Type 2
Kidney Disease, Chronic
Eligibility:
MALE
20-60 years
Phase:
NA
Brief Summary
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 an...
Detailed Description
Mechanistic studies conducted in healthy humans demonstrate a Glucagon-like peptide-1 (GLP-1)-mediated gut-kidney crosstalk. The expansion of extracellular fluid volume uncovers a natriuretic action o...
Eligibility Criteria
Inclusion
- 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)
- Discontinuation of treatment with selective sodium glucose transporter inhibitors (SGLT2i), dipeptidyl peptidase 4 inhibitors (DPP-4i), GLP-1R analogs, rapid-acting and mix insulin 30 days before screening.
Exclusion
- Immunosuppressive therapy within 30 days of screening
- Alcohol abuse
- Medical treatment with glucocorticoids
- Kidney transplantation
- Treatment for renal failure with dialysis
- Myocardial infarction within 3 months of screening
- Heart failure (NYHA 3-4)
- Dysregulated arterial hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥ 100 mm Hg)
- Liver disease (ALAT \>2 x normal value)
- Conditions which may interfere with the glucose metabolism according to the PI
- Severe claustrophobia
- Elements incompatible with MRI
- Abnormal kidney size and/or position
- Venous and arterial anatomy hindering catheterization.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06555146
Start Date
August 1 2024
End Date
March 1 2025
Last Update
August 15 2024
Active Locations (1)
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1
Bispebjerg Hospital, Department of Clinical Physiology & Nuclear Medicine
Copenhagen, Capital Region, Denmark, 2400