Diabetic NephropathyEarly Phase 1ReDNephNCT02704494
Resveratrol's Effects in Diabetic Nephropathy
A Early Phase 1 study testing Resveratrol and Losartan in people with Diabetic Nephropathy, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- Resveratrol and Losartan
- 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 siteIran
- Study dates
- Mar 2016to Feb 2017
- Phase
- Early Phase 1
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus (DM)
- Controlled blood sugar [fasting blood sugar (FBS) <130mg/dl and glycosylated hemoglobin (A1C)<7%
- Urine albumin >20mg/lit in two separate occasions during the last 3 months period
- Serum creatinin < or = 2mg/dl
Who cannot join
- Pregnancy
- Lactation
- Alcoholism
- Liver failure (acute or chronic)
- Renal failure: serum creatinin >2mg/dl
- Glomerulonephritis
Show all 14Show fewer
- Uncontrolled hypertension
- Congestive heart failure
- Prostate disease
- Malignancy
- Bilateral renal artery stenosis
- Any systemic disease other than DM
- Any infection or rheumatologic disorder
- Use of warfarin
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Shiraz, Fars
About this study
The aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy.
Read the detailed description
Diabetes mellitus (DM) is one of the most important public health burdens, and its prevalence has rapidly increased worldwide over the past decades. One of the most important complications of DM is nephropathy.
Resveratrol (3, 5, 4'-trihydroxystilbene) is a natural polyphenolic compound belongs to the large group of polyphenols found in different plant species. The richest natural source of resveratrol is Polygonum cuspidatum - a plant root extract of which have been used in oriental folk medicine. Considerable amounts of resveratrol were also found in skin of red grapes, peanuts, groundnuts, and red vine.
Resveratrol is considered to have beneficial effects on glucose tolerance and insulin sensitivity, the cardiovascular system, as it has been found to improve vasodilatation, ischaemic preconditioning, both of which seem to be the result of the activation of the endothelial NO synthase enzyme, and to inhibit both platelet aggregation and vascular smooth muscle cell proliferation. Resveratrol itself is an efficient antioxidant, as evidenced by both in vitro and in vivo studies, and, it has also been shown to improve diabetes-related impairments in animals.
We hypothesized that resveratrol may have a favorable effects on control of diabetic nephropathy. The aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy.
- Conditions
- Diabetic Nephropathy
- Being tested
- Resveratrol, Placebo, Losartan
- Keywords
- Resveratrol, Diabetes mellitus, Diabetes complications, Diabetic nephropathies, Proteinuria, Albuminuria, renal insufficiency
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Diabetes Complications, Proteinuria, Albuminuria, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDrug
Resveratrol 500mg daily
PlaceboDrug
Placebo 1 capsule daily
LosartanDrug
Losartan 12.5mg daily
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Experimental | Resveratrol + Losartan Receives: Drug: Resveratrol; Drug: Losartan |
| Placebo | Placebo comparator | Placebo + Losartan Receives: Drug: Placebo; Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine albumin level
Measured: 3 months
Serum creatinin
Measured: 3 months
Secondary outcomes (5)
Fasting blood sugar (FBS)
Measured: 3 months
Glycosylated hemoglobin (A1C)
Measured: 3 months
Liver aminotransferases (ALT and AST)
Measured: 3 months
Serum insulin level
Measured: 3 months
Number of patients with adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesbah Shams, MD, Shiraz University of Medical Sciences
- Investigators
- Gholamhossein Ranjbar Omrani, MD, Study chair, Endocrine and Metabolism Research Center, Shiraz University of Medical SciencesJamshid Roozbeh, MD, Principal investigator, Shiraz Nephrology and Urology Research Center, Shiraz University of Medical SciencesAzar Sattarinejad, MD, Principal investigator, Endocrine and Metabolism Research Center, Shiraz University of Medical SciencesMesbah Shams, MD, Principal investigator, Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704494
- Sponsor's protocol ID
- 93-01-49-9028
- Acronym
- ReDNeph
- Status last verified
- Oct 2017
- First submitted
- 4 Mar 2016
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
PubMed 37916745Sattarinezhad A, Roozbeh J, Shirazi Yeganeh B, Omrani GR, Shams M. Resveratrol reduces albuminuria in diabetic nephropathy: A randomized double-blind placebo-controlled clinical trial. Diabetes Metab. 2019 Jan;45(1):53-59. doi: 10.1016/j.diabet.2018.05.010. Epub 2018 Jun 8.
PubMed 29983230
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resveratrol's Effects in Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT02704494
- Acronym / sponsor ID
- ReDNeph / 93-01-49-9028
- Conditions
- Diabetic Nephropathy
- Keywords
- Resveratrol, Diabetes mellitus, Diabetes complications, Diabetic nephropathies, Proteinuria, Albuminuria, renal insufficiency
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 10 Mar 2016 (estimated)
- 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.
The aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy.
Detailed description
Diabetes mellitus (DM) is one of the most important public health burdens, and its prevalence has rapidly increased worldwide over the past decades. One of the most important complications of DM is nephropathy.
Resveratrol (3, 5, 4'-trihydroxystilbene) is a natural polyphenolic compound belongs to the large group of polyphenols found in different plant species. The richest natural source of resveratrol is Polygonum cuspidatum - a plant root extract of which have been used in oriental folk medicine. Considerable amounts of resveratrol were also found in skin of red grapes, peanuts, groundnuts, and red vine.
Resveratrol is considered to have beneficial effects on glucose tolerance and insulin sensitivity, the cardiovascular system, as it has been found to improve vasodilatation, ischaemic preconditioning, both of which seem to be the result of the activation of the endothelial NO synthase enzyme, and to inhibit both platelet aggregation and vascular smooth muscle cell proliferation. Resveratrol itself is an efficient antioxidant, as evidenced by both in vitro and in vivo studies, and, it has also been shown to improve diabetes-related impairments in animals.
We hypothesized that resveratrol may have a favorable effects on control of diabetic nephropathy. The aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Experimental | Drug: Resveratrol, Drug: LosartanResveratrol + Losartan |
| Placebo | Placebo comparator | Drug: Placebo, Drug: LosartanPlacebo + Losartan |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes mellitus (DM)
- Controlled blood sugar [fasting blood sugar (FBS) <130mg/dl and glycosylated hemoglobin (A1C)<7%
- Urine albumin >20mg/lit in two separate occasions during the last 3 months period
- Serum creatinin < or = 2mg/dl
Key exclusion criteria (14 listed)
- Pregnancy
- Lactation
- Alcoholism
- Liver failure (acute or chronic)
- Renal failure: serum creatinin >2mg/dl
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 |
|---|---|---|
| ResveratrolResveratrol 500mg daily | Drug | Resveratrol |
| PlaceboPlacebo 1 capsule daily | Drug | Placebo |
| LosartanLosartan 12.5mg daily | Drug | Placebo, Resveratrol |
Primary outcome
Urine albumin level
Time frame: 3 months
Serum creatinin
Time frame: 3 months
5 secondary outcomes
Fasting blood sugar (FBS)
Time frame: 3 months
Glycosylated hemoglobin (A1C)
Time frame: 3 months
Liver aminotransferases (ALT and AST)
Time frame: 3 months
Serum insulin level
Time frame: 3 months
Number of patients with adverse events
Time frame: 3 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 5 Oct 2017.
- Derived from this study: PubMed 37916745Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
- Derived from this study: PubMed 29983230Sattarinezhad A, Roozbeh J, Shirazi Yeganeh B, Omrani GR, Shams M. Resveratrol reduces albuminuria in diabetic nephropathy: A randomized double-blind placebo-controlled clinical trial. Diabetes Metab. 2019 Jan;45(1):53-59. doi: 10.1016/j.diabet.2018.05.010. Epub 2018 Jun 8.
- Individual participant dataSharing planned: Undecided
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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.
Gholamhossein Ranjbar Omrani, MD study chair
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Jamshid Roozbeh, MD principal investigator
Shiraz Nephrology and Urology Research Center, Shiraz University of Medical Sciences
Azar Sattarinejad, MD principal investigator
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Resveratrol and Losartan in people with Diabetic Nephropathy, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 4 inclusion and 14 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 5 Oct 2017. 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 Iran. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Urine albumin level (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02704494, which also lists 2 linked publications.
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 5 Oct 2017.