Type 1 Diabetic NephropathyPhase 2/3NCT07332819
Resveratol in Diabetic Nephropathy
A Phase 2/3 study testing Resveratol in people with Type 1 Diabetic Nephropathy, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 1 Diabetic Nephropathy
- What is being tested?
- Resveratol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jul 2024to 22 Aug 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Type 1 Diabetic Nephropathy
- Being tested
- Resveratol, Placebo
- Keywords
- Resveratol, Type 1 diabetes, Nephropathy, Children and adolescents
- Medical subject headings
- Diabetes Mellitus, Type 1, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratolDietary supplement
Resveratol oral supplementation
PlaceboOther
Oral placebo
| Study group | Role | What they receive |
|---|---|---|
| Resveratol | Experimental | Not described Receives: Dietary Supplement: Resveratol |
| Control | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in time in range at the study endpoint.
Measured: 6 months.
Secondary outcomes (1)
Change in serum KIM-1 measured by Elisa at the study endpoint.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start21 Jul 2024
- Primary completion22 Jul 2025
- Study completion22 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran yousef, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332819
- Sponsor's protocol ID
- MS 385/2021
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Resveratol I Pediatric and Adolescence With Type 1 Diabetic Nephropathy: A Six Months Preliminary Exploratory Trial
- ClinicalTrials.gov ID
- NCT07332819
- Acronym / sponsor ID
- MS 385/2021
- Conditions
- Type 1 Diabetic Nephropathy
- Keywords
- Resveratol, Type 1 diabetes, Nephropathy, Children and adolescents
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 21 Jul 2024 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratol | Experimental | Dietary Supplement: Resveratol |
| Control | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResveratolResveratol oral supplementation | Dietary supplement | Resveratol |
| PlaceboOral placebo | Other | Control |
Primary outcome
Improvement in time in range at the study endpoint.
Time frame: 6 months.
1 secondary outcome
Change in serum KIM-1 measured by Elisa at the study endpoint.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Resveratol in people with Type 1 Diabetic Nephropathy, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in time in range at the study endpoint. (time frame: 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.