Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147232
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2023-11-19
Brief Title:
Prevention of Chronic Kidney DiseaseCDK Progression in Type 1 Diabetes With Long Term Use of Sodium-Glucose-coTransporter Inhibitors Avoiding Kidney hypOxia
Sponsor:
Steno Diabetes Center Copenhagen
Organization:
Steno Diabetes Center Copenhagen
Study Overview
Official Title:
Prevention of CKD Progression in Type 1 Diabetes With Long Term Use of SGLTi Avoiding Kidney hypOxiaPLUTO
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLUTO
Brief Summary:
Background Sodium-glucose-cotransporter SGLT inhibition has been observed to reduce risk of cardiovascular events and kidney failure in persons with type 2 diabetes People with type 1 diabetes also have increased risk of cardiovascular and kidney disease and may benefit from SGLT-inhibition The exact mechanism of how SGLT-inhibition benefits the kidneys are yet unknown Change in renal hypoxia may be a factor
Objective The primary aim of this study is to assess the effects of 12 weeks SGLT-1 and 2 inhibition on renal oxygenation in persons with type 1 diabetes and chronic kidney disease
Further aims are to study if renal oxygen consumption and response to SGLT-inhibition differs between people of African-Caribbean or Northern European decent
Additionally effects on left ventricular ejection fraction kidney function and biomarkers in blood and urine will be explored
Method 12 weeks treatment with oral sotagliflozin or matching placebo as intervention Kidney oxygenation and perfusion parameters and left ventricular ejection fraction will be assessed by functional magnetic resonance imaging Kidney function and biomarkers will be assessed according to local hospital laboratory guidelines
Design Randomized double-blinded placebo-controlled cross over intervention study
Study population 69 persons with type 1 diabetes and diabetic kidney disease with albuminuria will be included 39 at Steno Diabetes Center Copenhagen 30 at Kings College London
Endpoints Primary end-point Change from 0 to 12 weeks in dynamic R2-weighted signal after treatment with sotagliflozin compared to placebo Secondary endpoints Change from 0 to 12 weeks with sotagliflozin compared with placebo on renal perfusion renal artery flow renal oxygen consumption renal parenchymal triglyceride fraction renal fibrosis left ventricular ejection fraction urinary albumin-creatinin ratio ketone bodies erythropoietin pro brain natriuretic peptide and plasma- and urine inflammation- and fibrosis biomarkers as well as difference after 12 weeks treatment in glomerular filtration rate
Timeframe Inclusion of patients from february 2024 Last visit september 2025 Presentation spring 2026 publication fall 2026
Objective The primary aim of this study is to assess the effects of 12 weeks SGLT-1 and 2 inhibition on renal oxygenation in persons with type 1 diabetes and chronic kidney disease
Further aims are to study if renal oxygen consumption and response to SGLT-inhibition differs between people of African-Caribbean or Northern European decent
Additionally effects on left ventricular ejection fraction kidney function and biomarkers in blood and urine will be explored
Method 12 weeks treatment with oral sotagliflozin or matching placebo as intervention Kidney oxygenation and perfusion parameters and left ventricular ejection fraction will be assessed by functional magnetic resonance imaging Kidney function and biomarkers will be assessed according to local hospital laboratory guidelines
Design Randomized double-blinded placebo-controlled cross over intervention study
Study population 69 persons with type 1 diabetes and diabetic kidney disease with albuminuria will be included 39 at Steno Diabetes Center Copenhagen 30 at Kings College London
Endpoints Primary end-point Change from 0 to 12 weeks in dynamic R2-weighted signal after treatment with sotagliflozin compared to placebo Secondary endpoints Change from 0 to 12 weeks with sotagliflozin compared with placebo on renal perfusion renal artery flow renal oxygen consumption renal parenchymal triglyceride fraction renal fibrosis left ventricular ejection fraction urinary albumin-creatinin ratio ketone bodies erythropoietin pro brain natriuretic peptide and plasma- and urine inflammation- and fibrosis biomarkers as well as difference after 12 weeks treatment in glomerular filtration rate
Timeframe Inclusion of patients from february 2024 Last visit september 2025 Presentation spring 2026 publication fall 2026
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None