Clinical trial NCT06441591: Clinical Outcome of Vinpocetine in Diabetic Nephropathy
Official title: The Effect of Vinpocetine on the Clinical Outcome of Patients With Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Diabetic Kidney Disease
Diabetic Nephropathies
Keywords: Vinpocetine
Diabetic nephropathy
diabetic kidney disease
UACR
ICAM
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 aren't 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 vinpocetine's promising profile and minimal reported side effects, this work aims to investigate the Vinpocetine's potential in treating diabetic nephropathy and associated complications.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years,
* Type II diabetic patients with CKD stage 3 (eGFR = 30 - 59 ml/min) or stage 4 (eGFR 15-29 ml/min),
* Albumin/Creatinine ratio (ACR): 30 - 300 μg /mg (microalbuminuria),
* Stable standard therapy for at least three months prior to inclusion in the study.

Exclusion Criteria:

* Kidney donor or recipient,
* Active malignancy,
* Pregnancy or breastfeeding,
* Known intolerance or hypersensitivity to VPN,
* Participation in other interventional trials,
* Patients with inadequate liver function (ALT and AST three times greater than the upper normal limits),
* Patients with severe comorbidities
* Patients receiving warfarin

Primary outcomes:
measure: level of Albuminuria
timeFrame: Samples will be measured at baseline and after 12 weeks
Secondary outcomes:
measure: Albumin: creatinine ratio (ACR)
timeFrame: Samples will be measured at baseline and after 12 weeks
measure: Serum Creatinine
timeFrame: Samples will be measured at baseline and after 12 weeks
measure: Blood urea nitrogen
timeFrame: Samples will be measured at baseline and after 12 weeks
measure: Hemoglobin A1c
timeFrame: Samples will be measured at baseline and after 12 weeks
measure: Fasting and postprandial blood glucose
timeFrame: Samples will be measured at baseline and after 12 weeks
measure: Lipid panel
timeFrame: Samples will be measured at baseline and after 12 weeks
measure: Body Mass index (BMI)
timeFrame: Samples will be measured at baseline and after 12 weeks
measure: Assessment of endothelial functions
timeFrame: Samples will be measured at baseline and after 12 weeks
measure: Quality of life (QoL) Assessment
timeFrame: Samples will be measured at baseline and after 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
state: Abbasseia
city: Cairo
country: Egypt
facility: Ain Shams Hospitals
state: Abbasseya
Study officials:
References: