Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618859
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Time-restricted Eating in Patients With Moderate Chronic Kidney Disease and Albuminuria
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Time-restricted Eating in Patients With Moderate Chronic Kidney Disease and Albuminuria A Pilot Randomized Open-label Double-arm Trial TRECK
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
TRECK
Brief Summary:
Chronic kidney disease CKD affects approximately 12 to 15 of adults worldwide with an increasing incidence expected Major causes include diabetic nephropathy hypertension and various glomerulonephritis Proteinuria is a key factor in identifying and assessing the risk of CKD progression
The precise pathophysiology of CKD is not fully understood but recent research highlights metabolic alterations particularly in lipid and glucose metabolism CKD progression is influenced by diet as evidenced by recent studies Interventions such as the ketogenic diet and time-restricted feeding show promising results in improving metabolism and may have beneficial effects on CKD
Our study aims to evaluate the impact of time-restricted eating TRE on proteinuria the decline in glomerular filtration rate and weight loss in patients with moderate CKD with albuminuria KDIGO stage 2-3 This will allow us to better understand the efficacy of this dietary approach tailored to the individual habits of participants
The primary outcome measure will be albuminuria before and after the 12-week intervention Secondary outcome measures will include the impact of fasting on blood pressure as assessed by 24-hour ambulatory monitoring body composition evaluated by DXA and BIA continuous glucose monitoring and blood hormone profiles Additionally the feasibility and safety of TRE in this population will be assessed
The precise pathophysiology of CKD is not fully understood but recent research highlights metabolic alterations particularly in lipid and glucose metabolism CKD progression is influenced by diet as evidenced by recent studies Interventions such as the ketogenic diet and time-restricted feeding show promising results in improving metabolism and may have beneficial effects on CKD
Our study aims to evaluate the impact of time-restricted eating TRE on proteinuria the decline in glomerular filtration rate and weight loss in patients with moderate CKD with albuminuria KDIGO stage 2-3 This will allow us to better understand the efficacy of this dietary approach tailored to the individual habits of participants
The primary outcome measure will be albuminuria before and after the 12-week intervention Secondary outcome measures will include the impact of fasting on blood pressure as assessed by 24-hour ambulatory monitoring body composition evaluated by DXA and BIA continuous glucose monitoring and blood hormone profiles Additionally the feasibility and safety of TRE in this population will be assessed
Detailed Description:
None
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