Resveratol in Diabetic Nephropathy

Efficacy and Safety of Resveratol I Pediatric and Adolescence With Type 1 Diabetic Nephropathy: A Six Months Preliminary Exploratory Trial

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetic Nephropathy
• Intervention / Treatment: Other: Placebo; Dietary supplement: Resveratol

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Medicine, Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Hyper- or hypo-thyroidism.
• Hepatitis virus infection (B or C) or any evidence of infection.
• 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).
• Serious co-morbidities.
• 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.
• Patients who have an allergy to grapes, berries, and peanuts.
• Participation in a previous investigational drug study within 3 months preceding screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Other: Placebo; Oral placebo
Experimental: Resveratol	Dietary supplement: Resveratol; Resveratol oral supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in time in range at the study endpoint.	6 months.

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in serum KIM-1 measured by Elisa at the study endpoint.	6 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2024
• Primary Completion (Actual): July 22, 2025
• Study Completion (Actual): August 22, 2025

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Actual): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Type 1 diabetes; Nephropathy; Children and adolescents; Resveratol
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Kidney Diseases
• Other Study ID Numbers: MS 385/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No