Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555146
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Semaglutides Effect on Renal Hemodynamics and Function in Patients With Type 2 Diabetes Mellitus and Nephropathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Glucagon-like Peptide-1s Effect on Renal Regional Blood Flow and the Renal Function in Patients With Type 2 Diabetes Mellitus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Sema-RMA
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 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
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
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 of GLP-1 This feed-forward natriuretic system is associated with high renal extraction of GLP-1 suppression in circulating angiotensin II levels and increased renal medullary and cortical perfusion and oxygenation Besides potent glucose-lowering actions Glucagon-like peptide-1 receptor agonists GLP-1RAs improve body weight blood pressure and dyslipidemia and cardiovascular and renal outcome trials demonstrate beneficial actions of GLP-1RAs used in patients with type 2 diabetes mellitus T2DM
Thus the beneficial cardiovascular effects of GLP-1 may partly be related to renoprotection and might represent the restoration of the gut-kidney crosstalk
The aim of the present study is to investigate possible mechanisms behind the renal effects of semaglutide in patients with type 2 diabetes mellitus and moderate chronic kidney disease
This is a double-blinded placebo-controlled crossover study and patients will participate in two independent and randomized study periods with a washout period of around 4 weeks in between
Fifteen male participants with type 2 diabetes mellitus in the age group 20-60 years are screened randomized and expected to complete the present study Informed consent is obtained before the screening meeting followed by a 30-day run-in period prior to study days
The two study periods each extend over 8 days where all participants consume a controlled diet with fixed salt intake corresponding to a daily intake of 50-70 mmol 2 mmolkg sodium for 7 days On the fourth day before each of the two baseline trials 24-hour urine collection will be performed Throughout the 7 days water intake will be ad libitum and physical activity will not be allowed
Each period consists of Baseline day day 5 and Intervention day day 8
Renal flow perfusion and oxygenation are measured on both days using multiparametric MRI
Glomerular filtration rate GFR is measured using Tc99m-Diethylenetriamine pentaacetic acid DTPA plasma clearance
After conducting the baseline study the participant is given a subcutaneous injection of either semaglutide or placebo
During the intervention study MRI is followed by catheterization of a renal vein via the femoral vein the Seldinger technique for blood sampling
Thus the beneficial cardiovascular effects of GLP-1 may partly be related to renoprotection and might represent the restoration of the gut-kidney crosstalk
The aim of the present study is to investigate possible mechanisms behind the renal effects of semaglutide in patients with type 2 diabetes mellitus and moderate chronic kidney disease
This is a double-blinded placebo-controlled crossover study and patients will participate in two independent and randomized study periods with a washout period of around 4 weeks in between
Fifteen male participants with type 2 diabetes mellitus in the age group 20-60 years are screened randomized and expected to complete the present study Informed consent is obtained before the screening meeting followed by a 30-day run-in period prior to study days
The two study periods each extend over 8 days where all participants consume a controlled diet with fixed salt intake corresponding to a daily intake of 50-70 mmol 2 mmolkg sodium for 7 days On the fourth day before each of the two baseline trials 24-hour urine collection will be performed Throughout the 7 days water intake will be ad libitum and physical activity will not be allowed
Each period consists of Baseline day day 5 and Intervention day day 8
Renal flow perfusion and oxygenation are measured on both days using multiparametric MRI
Glomerular filtration rate GFR is measured using Tc99m-Diethylenetriamine pentaacetic acid DTPA plasma clearance
After conducting the baseline study the participant is given a subcutaneous injection of either semaglutide or placebo
During the intervention study MRI is followed by catheterization of a renal vein via the femoral vein the Seldinger technique for blood sampling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None