Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654921
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2021-07-03
Brief Title:
Remote Ischemic Conditioning for the Treatment of Diabetic Kidney Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Safety and Efficacy of Remote Ischemic Conditioning for the Treatment of Diabetic Kidney Disease a Single-center Double-blinded Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
RIC-DKD
Brief Summary:
Chronic kidney disease CKD is a growing epidemic affecting 10 of the population worldwide Significantly diabetic kidney disease DKD is the main cause of CKD and affects approximately 40 of patients with diabetes Approximately 10 of patients with early-stage CKD and approximately half of patients with advanced-stage CKD suffer progression to renal failure and require dialysis or transplantation to survive Moreover DKD progresses particularly rapidly and has a poor prognosis accounting for almost 50 of end-stage renal disease ESRD cases Dialysis in particular is a burdensome therapy associated with poor patient outcomes and high societal and economic costs Clinical studies using RIP have demonstrated protection against ischemic target renal damage in a variety of acute and chronic clinical settings In the renal setting RIP performed in dialysis patients is known to abrogate brain heart and liver ischemia occurring during hemodialysis treatments RIP may play a role in reducing the incidence of cardiac surgery-associated acute kidney injury However whether RIP can improve the renal function of patients with DKD is unclear and is worthy of further study
Our overarching hypothesis is that RIP performed in DKD patients could delay progression to renal failure by abrogating progressive ischemic damage in the failing kidney The present proposal is a pilot study addressing this hypothesis and is aimed at generating proof-of-concept and feasibility data on the benefits of RIP in patients with DKD
Our overarching hypothesis is that RIP performed in DKD patients could delay progression to renal failure by abrogating progressive ischemic damage in the failing kidney The present proposal is a pilot study addressing this hypothesis and is aimed at generating proof-of-concept and feasibility data on the benefits of RIP in patients with DKD
Detailed Description:
Chronic kidney disease CKD is a growing epidemic affecting 10 of the population worldwide Significantly diabetic kidney disease DKD is the main cause of CKD and affects approximately 40 of patients with diabetes Approximately 10 of patients with early-stage CKD and approximately half of patients with advanced-stage CKD suffer progression to renal failure and require dialysis or transplantation to survive Moreover DKD progresses particularly rapidly and has a poor prognosis accounting for almost 50 of end-stage renal disease ESRD cases Dialysis in particular is a burdensome therapy associated with poor patient outcomes and high societal and economic costs Strategies to prevent progression to renal failure focus on exquisite blood pressure control renin-angiotensin-aldosterone system RAAS inhibition for proteinuria DKD and glycemic control with the use of sodium-glucose cotransporter-2 SGLT-2 inhibitors in patients with diabetes Even so despite the optimization of these parameters many high-risk DKD patients will progress to renal failure Recurrent ischemic damage to the failing and fibrotic kidney appears to be one of the final common pathways of progressive kidney damage in late-stage DKD irrespective of the original cause of kidney disease Specific strategies to alter this pathway in DKD have not yet been developed In this context it is crucial to seek novel pharmaceutical or nonpharmaceutical approaches to optimize the treatment of DKD
With the progression of DKD renal interstitial fibrosis intensifies leading to severe ischemia and hypoxia of kidney cells and ultimately leading to ESRD Therefore effectively delaying the process of renal fibrosis can slow or even reverse the process of DKD Hypoxia is characterized by an insufficient supply of oxygen to organs and hypoxia-inducible factor HIF regulates gene transcription in hypoxia Appropriate renal hypoxia can activate HIF-1α and suppress HIF-2α improving the ability of the kidney to adapt to hypoxia reducing transforming growth factor TGF-β pathway activity and further inhibiting fibrosis development Therefore increasing the expression of HIF-1 in renal tissue may be a new method to delay renal interstitial fibrosis and the progression of DKD to ESRD Previous studies have provided evidence that HIF-1α participates in remote ischemic preconditioning RIP HIF-1α levels are significantly increased in the peripheral blood after RIP is implemented Therefore we speculated that RIP may have a therapeutic effect on DKD
Ischemic conditioning occurs when a transient episode of ischemia reduces the effect of a subsequent larger ischemic insult Similar levels of protection can be achieved by RIP RIP is a noninvasive physical therapy that induces remote vital organs to adapt to ischemia through repeated short-term ischemia-reperfusion training on nonvital organs such as limbs thereby improving their tolerance to ischemic injury and enabling them to withstand subsequent fatal ischemic events Clinical studies using RIP have demonstrated protection against ischemic target renal damage in a variety of acute and chronic clinical settings In the renal setting RIP performed in dialysis patients is known to abrogate brain heart and liver ischemia occurring during hemodialysis treatments RIP may play a role in reducing the incidence of cardiac surgery-associated acute kidney injury However whether RIP can improve the renal function of patients with DKD is unclear and is worthy of further study
Our overarching hypothesis is that RIP performed in DKD patients could delay progression to renal failure by abrogating progressive ischemic damage in the failing kidney The present proposal is a pilot study addressing this hypothesis and is aimed at generating proof-of-concept and feasibility data on the benefits of RIP in patients with DKD
With the progression of DKD renal interstitial fibrosis intensifies leading to severe ischemia and hypoxia of kidney cells and ultimately leading to ESRD Therefore effectively delaying the process of renal fibrosis can slow or even reverse the process of DKD Hypoxia is characterized by an insufficient supply of oxygen to organs and hypoxia-inducible factor HIF regulates gene transcription in hypoxia Appropriate renal hypoxia can activate HIF-1α and suppress HIF-2α improving the ability of the kidney to adapt to hypoxia reducing transforming growth factor TGF-β pathway activity and further inhibiting fibrosis development Therefore increasing the expression of HIF-1 in renal tissue may be a new method to delay renal interstitial fibrosis and the progression of DKD to ESRD Previous studies have provided evidence that HIF-1α participates in remote ischemic preconditioning RIP HIF-1α levels are significantly increased in the peripheral blood after RIP is implemented Therefore we speculated that RIP may have a therapeutic effect on DKD
Ischemic conditioning occurs when a transient episode of ischemia reduces the effect of a subsequent larger ischemic insult Similar levels of protection can be achieved by RIP RIP is a noninvasive physical therapy that induces remote vital organs to adapt to ischemia through repeated short-term ischemia-reperfusion training on nonvital organs such as limbs thereby improving their tolerance to ischemic injury and enabling them to withstand subsequent fatal ischemic events Clinical studies using RIP have demonstrated protection against ischemic target renal damage in a variety of acute and chronic clinical settings In the renal setting RIP performed in dialysis patients is known to abrogate brain heart and liver ischemia occurring during hemodialysis treatments RIP may play a role in reducing the incidence of cardiac surgery-associated acute kidney injury However whether RIP can improve the renal function of patients with DKD is unclear and is worthy of further study
Our overarching hypothesis is that RIP performed in DKD patients could delay progression to renal failure by abrogating progressive ischemic damage in the failing kidney The present proposal is a pilot study addressing this hypothesis and is aimed at generating proof-of-concept and feasibility data on the benefits of RIP in patients with DKD
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