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

Launched by BISPEBJERG HOSPITAL · Aug 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called semaglutide on kidney function in people with type 2 diabetes and moderate chronic kidney disease. Semaglutide is a type of treatment that helps control blood sugar levels, and researchers want to see how it impacts blood flow to the kidneys, how well the kidneys filter blood, and other important kidney functions. The trial is designed to be fair, using a method where some participants receive the medication while others receive a placebo (a non-active treatment) without knowing which one they are getting.

To participate in this study, individuals must be men aged 18 to 75 who have been diagnosed with type 2 diabetes and have specific kidney function measurements. They should also meet certain health criteria, such as being on stable blood pressure medication and not having serious heart or liver conditions. Participants will undergo various tests to assess their kidney health and other related functions, and they will receive careful monitoring throughout the study. This trial is not yet recruiting participants, but it aims to provide valuable insights that could benefit others with similar health issues in the future.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.