Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441591
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-05-27
Brief Title:
Clinical Outcome of Vinpocetine in Diabetic Nephropathy
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
The Effect of Vinpocetine on the Clinical Outcome of Patients With Diabetic Nephropathy
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The goal of this controlled randomized clinical trial is to evaluate the effect of vinpocetine on clinical outcomes on the diabetic nephropathy patients
The following will be evaluated anthropometrics kidney functions glucose panel lipid panel ICAM-1 quality of life
Participants will receive either vinpocetine or placebo twice daily for 3 months
The following will be evaluated anthropometrics kidney functions glucose panel lipid panel ICAM-1 quality of life
Participants will receive either vinpocetine or placebo twice daily for 3 months
Detailed Description:
Diabetes mellitus affects around 537 million people globally projected to reach over 700 million by 2045 Egypt is notably impacted ranking tenth in prevalence and contributing significantly to chronic kidney disease blindness and stroke Diabetic nephropathy DN arises as a severe complication affecting about 50 of type 2 diabetes patients and leading to end-stage kidney disease Its pathogenesis involves complex mechanisms like persistent hyperglycemia inflammation oxidative stress and endothelial dysfunction culminating in kidney damage and subsequently fibrosis
Current treatments focus on managing blood glucose pressure and lipid levels often using drugs that target the renin-angiotensin-aldosterone system However these therapies arent always sufficient to prevent progression to end-stage renal disease Therefore exploring new approaches is crucial
Vinpocetine a derivative of Vinca minor leaves is a selective inhibitor of phosphodiesterase type 1 PDE1 It has noteworthy antioxidant anti-inflammatory and anti-apoptotic properties
Clinical and experimental studies suggest its potential in various conditions including neurodegenerative disorders cardiovascular diseases and inflammation-related ailments Notably it has shown promising effects in improving endothelial function and reducing inflammatory markers like TNF-α and IL-6
In kidney injury models Vinpocetine has demonstrated nephroprotective effects improving kidney function markers reducing albumin excretion and decreasing renal hypertrophy It can also exert its antioxidant effects through the restoration of the depleted GSH content and the attenuation of the increase in MDA levels In a clinical trial investigating the effect of vinpocetine in acute ischemic stroke patients vinpocetine inhibited the upregulation of TNF-α IL-6 MCP-1 ICAM-1 VCAM-1 as well as CRP in blood plasma It also appears to impact atherosclerosis by positively affecting lipid profiles and reducing atherosclerosis lesion formation through mechanisms like inhibition of NF-κB and modulation of ox-LDL receptors
Based on vinpocetines promising profile and minimal reported side effects this work aims to investigate the Vinpocetines potential in treating diabetic nephropathy and associated complications
Current treatments focus on managing blood glucose pressure and lipid levels often using drugs that target the renin-angiotensin-aldosterone system However these therapies arent always sufficient to prevent progression to end-stage renal disease Therefore exploring new approaches is crucial
Vinpocetine a derivative of Vinca minor leaves is a selective inhibitor of phosphodiesterase type 1 PDE1 It has noteworthy antioxidant anti-inflammatory and anti-apoptotic properties
Clinical and experimental studies suggest its potential in various conditions including neurodegenerative disorders cardiovascular diseases and inflammation-related ailments Notably it has shown promising effects in improving endothelial function and reducing inflammatory markers like TNF-α and IL-6
In kidney injury models Vinpocetine has demonstrated nephroprotective effects improving kidney function markers reducing albumin excretion and decreasing renal hypertrophy It can also exert its antioxidant effects through the restoration of the depleted GSH content and the attenuation of the increase in MDA levels In a clinical trial investigating the effect of vinpocetine in acute ischemic stroke patients vinpocetine inhibited the upregulation of TNF-α IL-6 MCP-1 ICAM-1 VCAM-1 as well as CRP in blood plasma It also appears to impact atherosclerosis by positively affecting lipid profiles and reducing atherosclerosis lesion formation through mechanisms like inhibition of NF-κB and modulation of ox-LDL receptors
Based on vinpocetines promising profile and minimal reported side effects this work aims to investigate the Vinpocetines potential in treating diabetic nephropathy and associated complications
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?:
None
Is an FDA AA801 Violation?:
None