Diabetic Kidney DiseasePhase 2/3NCT06441591
Clinical Outcome of Vinpocetine in Diabetic Nephropathy
A Phase 2/3 study testing Vinpocetine and Standard Therapy in people with Diabetic Kidney Disease and Diabetic Nephropathies, run by Ain Shams University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Kidney Disease, Diabetic Nephropathies
- What is being tested?
- Vinpocetine and Standard Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Jul 2024to 1 Jun 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Not yet recruiting
Ain Shams University Hospital
Cairo, Abbasseia, 11588
Tamer El Said, 01227366062, drtamer_elsaid@med.asu.edu.eg
- Recruiting
Ain Shams Hospitals
Cairo, Abbasseya, 11588
Tamer El Said, 01227366062
About this study
Official title: The Effect of Vinpocetine on the Clinical Outcome of Patients With Diabetic Nephropathy
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.
Read the 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
- Being tested
- Vinpocetine, Standard Therapy, Placebo
- Keywords
- Vinpocetine, Diabetic nephropathy, diabetic kidney disease, UACR, ICAM
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinpocetineDrug
Vinca derivative of apovincamine, phosphodiestrase 1 inhibitor, sodium-gated voltage channel
Standard TherapyDrug
Anti-hypertensive and anti-diabetic medications according to the the institution's protocol
PlaceboOther
Starch-filled capsules, matching those of the intervention
| Study group | Role | What they receive |
|---|---|---|
| Vinpocetine + Standard Therapy | Experimental | Vinpocetine capsules, 30 mg, twice daily, with meals for 3 months Receives: Drug: Vinpocetine; Drug: Standard Therapy |
| Placebo + Standard Therapy | Placebo comparator | Placebo, twice daily, with meals for 3 months Receives: Drug: Standard Therapy; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of Albuminuria
assessment of the amount of albumin excreted in urine
Measured: Samples will be measured at baseline and after 12 weeks
Secondary outcomes (9)
Albumin: creatinine ratio (ACR)
The urine ACR is calculated by dividing the urine albumin concentration by the urine creatinine concentration to account for differences in urine volume and more closely approximate the gold standard, 24-hour urine albumin excretion.
Measured: Samples will be measured at baseline and after 12 weeks
Serum Creatinine
assessment of the serum level of creatinine
Measured: Samples will be measured at baseline and after 12 weeks
Blood urea nitrogen
assessment of the level of blood urea nitrogen in serum
Measured: Samples will be measured at baseline and after 12 weeks
Hemoglobin A1c
assessment of the level of glycated hemoglobin
Measured: Samples will be measured at baseline and after 12 weeks
Fasting and postprandial blood glucose
Evaluation of blood level glucose after 8-hrs fasting and 2-hrs postprandial
Measured: Samples will be measured at baseline and after 12 weeks
Lipid panel
Serum Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Triglycerides
Measured: Samples will be measured at baseline and after 12 weeks
Body Mass index (BMI)
The BMI will be calculated using the following formula BMI=Weight(kg)/ height(m)^2
Measured: Samples will be measured at baseline and after 12 weeks
Assessment of endothelial functions
Serum ICAM-1 using ELISA
Measured: Samples will be measured at baseline and after 12 weeks
Quality of life (QoL) Assessment
Quality of Life (QoL) assessment using Diabetes-39 (D-39) Questionnaire. The D-39 questionnaire is a multi-dimensional, self-administrating, diabetes-specific scale. It consists of 39 items in five domains, namely energy, and mobility (15 items), diabetes control (12 items), anxiety and worry (4 items), social and peer burden (5 items), and sexual functioning (3 items). Scores are marked on a seven-point scale ranging from 1 (not affected at all) to 7 (extremely affected).
The raw score resulting from the summation of each dimension will then be transformed linearly to 0 to 100 scales, using the following formula:
(Raw score - minimum value)/(maximum value - minimum value) × 100
A score of 0 indicates the least impact on QoL, and a score of 100 indicates the maximum impact on QoL
Measured: Samples will be measured at baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start10 Jul 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Hesham Bahram, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441591
- Sponsor's protocol ID
- 238
- Status last verified
- Jul 2024
- First submitted
- 27 May 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vinpocetine on the Clinical Outcome of Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT06441591
- Acronym / sponsor ID
- 238
- Conditions
- Diabetic Kidney Disease, Diabetic Nephropathies
- Keywords
- Vinpocetine, Diabetic nephropathy, diabetic kidney disease, UACR, ICAM
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vinpocetine + Standard Therapy | Experimental | Drug: Vinpocetine, Drug: Standard TherapyVinpocetine capsules, 30 mg, twice daily, with meals for 3 months |
| Placebo + Standard Therapy | Placebo comparator | Drug: Standard Therapy, Other: PlaceboPlacebo, twice daily, with meals for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Kidney donor or recipient,
- Active malignancy,
- Pregnancy or breastfeeding,
- Known intolerance or hypersensitivity to VPN,
- Participation in other interventional trials,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VinpocetineVinca derivative of apovincamine, phosphodiestrase 1 inhibitor, sodium-gated voltage channel | Drug | Vinpocetine + Standard Therapy |
| Standard TherapyAnti-hypertensive and anti-diabetic medications according to the the institution's protocol | Drug | Placebo + Standard Therapy, Vinpocetine + Standard Therapy |
| PlaceboStarch-filled capsules, matching those of the intervention | Other | Placebo + Standard Therapy |
Primary outcome
level of Albuminuria
Time frame: Samples will be measured at baseline and after 12 weeks
assessment of the amount of albumin excreted in urine
9 secondary outcomes
Albumin: creatinine ratio (ACR)
Time frame: Samples will be measured at baseline and after 12 weeks
Serum Creatinine
Time frame: Samples will be measured at baseline and after 12 weeks
Blood urea nitrogen
Time frame: Samples will be measured at baseline and after 12 weeks
Hemoglobin A1c
Time frame: Samples will be measured at baseline and after 12 weeks
Fasting and postprandial blood glucose
Time frame: Samples will be measured at baseline and after 12 weeks
Lipid panel
Time frame: Samples will be measured at baseline and after 12 weeks
Body Mass index (BMI)
Time frame: Samples will be measured at baseline and after 12 weeks
Assessment of endothelial functions
Time frame: Samples will be measured at baseline and after 12 weeks
Quality of life (QoL) Assessment
Time frame: Samples will be measured at baseline and after 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
Related trials for Diabetic Kidney Disease
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vinpocetine and Standard Therapy in people with Diabetic Kidney Disease and Diabetic Nephropathies, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamer El Said (201227366062, drtamer_elsaid@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of Albuminuria (time frame: Samples will be measured at baseline and after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.