Type 1 Diabetic Nephropathy
Conditions
Keywords
Resveratol, Type 1 diabetes, Nephropathy, Children and adolescents
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTResveratol
Resveratol oral supplementation
OTHERPlacebo
Oral placebo
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in time in range at the study endpoint. | 6 months. |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum KIM-1 measured by Elisa at the study endpoint. | 6 months |
Countries
Egypt
Outcome results
None listed