Faculty of Medicine, Ain Shams University
Cairo, Egypt
NCT Number: NCT07332819
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.
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Notify Me12 year–18 year
All sexes
Interventional
Phase 2 / Phase 3
Cairo, Egypt
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Resveratol oral supplementation
Oral placebo
Time frame: 6 months.
Time frame: 6 months
Ain Shams University
Other
Efficacy and Safety of Resveratol I Pediatric and Adolescence With Type 1 Diabetic Nephropathy: A Six Months Preliminary Exploratory Trial
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