Clinical Outcome of Vinpocetine in Diabetic Nephropathy

NCT ID: NCT06441591

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2025-06-01

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.

Conditions

Diabetic Kidney Disease; Diabetic Nephropathies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vinpocetine + Standard Therapy

Vinpocetine capsules, 30 mg, twice daily, with meals for 3 months

Group Type: EXPERIMENTAL

Vinpocetine

Intervention Type: DRUG

Vinca derivative of apovincamine, phosphodiestrase 1 inhibitor, sodium-gated voltage channel

Standard Therapy

Intervention Type: DRUG

Anti-hypertensive and anti-diabetic medications according to the the institution's protocol

Placebo + Standard Therapy

Placebo, twice daily, with meals for 3 months

Group Type: PLACEBO_COMPARATOR

Standard Therapy

Intervention Type: DRUG

Anti-hypertensive and anti-diabetic medications according to the the institution's protocol

Placebo

Intervention Type: OTHER

Starch-filled capsules, matching those of the intervention

Interventions

Vinpocetine

Vinca derivative of apovincamine, phosphodiestrase 1 inhibitor, sodium-gated voltage channel

Intervention Type: DRUG

Standard Therapy

Anti-hypertensive and anti-diabetic medications according to the the institution's protocol

Intervention Type: DRUG

Placebo

Starch-filled capsules, matching those of the intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Salma Hesham Bahram

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University Hospital

Cairo, Abbasseia, Egypt

Site Status: NOT_YET_RECRUITING

Ain Shams Hospitals

Cairo, Abbasseya, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Tamer El Said

Role: CONTACT

drtamer_elsaid@med.asu.edu.eg

201227366062

Facility Contacts

Tamer El Said

Role: primary

drtamer_elsaid@med.asu.edu.eg

01227366062

Tamer El Said

Role: primary

01227366062

Other Identifiers

238

Identifier Type: -

Identifier Source: org_study_id