NCT07332819CompletedPhase 2/3
Resveratol in Diabetic Nephropathy
Efficacy and Safety of Resveratol I Pediatric and Adolescence With Type 1 Diabetic Nephropathy: A Six Months Preliminary Exploratory Trial
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
Background: Food-derived compounds have been shown to have beneficial effects in type 1 diabetes mellitus (T1DM). Among these compounds, resveratrol (3,5,4'-trihydroxystilbene) which is found in grapes, peanuts, cranberries. Resveratrol has a wide range of effects including antimicrobial, anti-inflammatory, anti-apoptotic, anticancer, anti-oxidative and cardio- protective effects. Resveratrol is capable of inducing beneficial effects in diabetic animals and thereby, ameliorates diabetes. Recently, resveratrol showed beneficial effects in adults with T1DM. Objectives: Therefore, we performed a randomized-controlled trial to assess the effect of oral resveratrol supplementation on glycemic control, lipid profile and kidney injury molecule-1 (KIM-1) levels in pediatric patients with T1DM and diabetic nephropathy. Methods: This study included 60 children and adolescents with T1DM. Enrolled patients aged 12-18 years with disease duration \> 5 years and have diabetic nephropathy. Patients were randomly assigned into two groups; intervention group (group A) who received oral resveratrol tablets 250 mg twice daily. The other group (group B) did not receive any supplementation and served as a control group. Both groups were followed-up for 6 months with assessment of fasting blood glucose (FBG), HbA1c, urinary albumin creatinine ratio (UACR) and KIM-1 levels. Insulin sensitivity score and estimated glucose disposal rate (eGDR) were calculated.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 18 Dec 2025
- Start date
- 21 Jul 2024
- Primary completion date
- 22 Jul 2025
- Lead sponsor
- Ain Shams University
- Diseases
- Chronic kidney disease, Type 1 diabetes
- NCT number
- NCT07332819
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 60
- From 21 Jul 2024 to the primary completion date, 22 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hypoglycaemic unawareness or recurrent severe hypoglycaemic episode in 6 months prior to recruitment.
- Recurrent diabetic ketoacidosis (more than 2 episodes in the previous 12 months).
- Patients were already on anti-hypertensive drugs or any antioxidant therapy such as vitamin supplements.
- Taking any vitamins or food supplements one month before study.
- Participation in a previous investigational drug study within 3 months preceding screening.
Other illness
- Patients with history of liver disease or any disorder likely to impair liver functions or elevated liver enzymes (aminotransferases levels higher than twice the upper normal limit).
- Patients with renal impairment due to cause other than diabetes.
- Patients with hypertension.
- Hepatitis virus infection (B or C) or any evidence of infection.
- Patients who have an allergy to grapes, berries, and peanuts.
Other
- Hyper- or hypo-thyroidism.
- Serious co-morbidities.
Who the study is looking for
- Patients with T1DM.
- Patients aged 12-18 years with at least 5 years disease duration.
- Active diabetic nephropathy in the form of microalbuminuria (urinary albumin excretion \[UAE\] 30-299 mg/g creatinine). The presence of persistent microalbuminuria was confirmed by finding two or all of three samples abnormal over a 3- to 6-months period prior to study despite angiotensin converting enzyme inhibitors (ACE-Is) (Tabaei et al., 2001; Molitch et al., 2004; Donaghueet al., 2018).
- Hemoglobin A1c (HbA1c) ≤9.0%.
- Patients on regular visit to clinic.
- Patients on regular insulin therapy.
Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine-Ain Shams University Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.