Diabetic Kidney Disease Clinical Trial
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.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | June 1, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams Hospitals | Cairo | Abbasseya |
Egypt | Ain Shams University Hospital | Cairo | Abbasseia |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | level of Albuminuria | assessment of the amount of albumin excreted in urine | Samples will be measured at baseline and after 12 weeks | |
Secondary | 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. | Samples will be measured at baseline and after 12 weeks | |
Secondary | Serum Creatinine | assessment of the serum level of creatinine | Samples will be measured at baseline and after 12 weeks | |
Secondary | Blood urea nitrogen | assessment of the level of blood urea nitrogen in serum | Samples will be measured at baseline and after 12 weeks | |
Secondary | Hemoglobin A1c | assessment of the level of glycated hemoglobin | Samples will be measured at baseline and after 12 weeks | |
Secondary | Fasting and postprandial blood glucose | Evaluation of blood level glucose after 8-hrs fasting and 2-hrs postprandial | Samples will be measured at baseline and after 12 weeks | |
Secondary | Lipid panel | Serum Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Triglycerides | Samples will be measured at baseline and after 12 weeks | |
Secondary | Body Mass index (BMI) | The BMI will be calculated using the following formula BMI=Weight(kg)/ height(m)^2 | Samples will be measured at baseline and after 12 weeks | |
Secondary | Assessment of endothelial functions | Serum ICAM-1 using ELISA | Samples will be measured at baseline and after 12 weeks | |
Secondary | 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 |
Samples will be measured at baseline and after 12 weeks |
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