Type 2 Diabetes MellitusPhase 3NCT02244879
Effects of Resveratrol on Inflammation in Type 2 Diabetic Patients
A Phase 3 study testing resveratrol in people with Type 2 Diabetes Mellitus and Inflammation, run by University of Turin, Italy at 1 site in Italy.
Trial summary
This research will investigate the effect of resveratrol on inflammatory mediators in type 2 diabetic patients in vivo. The investigators will also investigate the hypothesis that resveratrol has an antioxidant activity, improves insulin sensitivity and lipid pattern, down-regulates bone-turnover. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Inflammation, Insulin Resistance
- What is being tested?
- resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2013to Feb 2016
- Phase
- Phase 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 35 years of age and older
- Type 2 diabetes with body mass index (BMI)<35 kg/m2
- Subjects on hypoglycemic agents other than insulin
- Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements.
Who cannot join
- Subjects on any antioxidant medication
- Patient on non-steroidal anti-inflammatory drug, steroids or insulin
- On any agent with significant antioxidant properties
- History of drug or alcohol abuse
- Liver or kidney diseases
- Any life threatening diseases
Show all 10Show fewer
- Allergy to peanuts, grapes, wine, mulberries
- Pregnant women
- Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous four Weeks
- Subjects on anticoagulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Resveratrol on Inflammation in Type 2 Diabetic Patients. A Double-blind Randomized Controlled Trial
This research will investigate the effect of resveratrol on inflammatory mediators in type 2 diabetic patients in vivo.
The investigators will also investigate the hypothesis that resveratrol has an antioxidant activity, improves insulin sensitivity and lipid pattern, down-regulates bone-turnover.
Read the detailed description
Despite a large body of evidence demonstrating promising effects of resveratrol in rodents, human studies are still lacking and both preventive and therapeutic value of resveratrol in humans remains to be elucidated. The published evidence is not sufficiently strong to recommend for the administration of resveratrol to humans, beyond dietary sources. On the other hand, animal data are promising in prevention of various cancer types, coronary heart diseases and diabetes which strongly indicate the need for human clinical trials.
Furthermore, data are lacking either about safety during long-term administration, or on the efficacy of resveratrol administration in patients with chronic illnesses, such as diabetes mellitus.
The main objective of this study is to investigate the effect of resveratrol on inflammatory mediators in type 2 diabetic patients in vivo.
This research will investigate the hypothesis that resveratrol, when given orally to type 2 diabetic subjects for 24 weeks induces a decrease in values of high-sensitivity CRP (C-reactive protein) (primary outcome measure), IL-6 (Interleukin-6), PTX3 (pentraxin 3).
The investigators will also investigate the hypothesis that resveratrol has an antioxidant activity, improves insulin sensitivity and lipid pattern, down-regulates bone-turnover. Secondary outcomes are therefore variations in the following variables: TAS (total antioxidant status), glycemia, glycated hemoglobin (HbA1c), Homeostasis model assessment of insulin resistance (HOMA-IR), total and HDL-cholesterol, triglycerides, adiponectin, body composition (evaluated by Dual-emission X-ray absorptiometry DXA-), bone mineral density (DXA).
Finally, the investigators are interested in evaluating efficacy, safety and tolerability of two different dosages of resveratrol: 500 mg/day and 40 mg/day.
- Conditions
- Type 2 Diabetes Mellitus, Inflammation, Insulin Resistance, Other Disorders of Bone Density and Structure
- Being tested
- resveratrol
- Keywords
- resveratrol, type 2 diabetes mellitus, inflammation, insulin resistance, body composition, bone mass
- Medical subject headings
- Diabetes Mellitus, Type 2, Inflammation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resveratrolDietary supplement
arm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | In this arm, 64 patients will receive a tablet of placebo once/day for 6 months Receives: Dietary Supplement: resveratrol |
| resveratrol 40 | Experimental | In this arm, 64 patients will receive a tablet of 40mg resveratrol once/day for 6 months Receives: Dietary Supplement: resveratrol |
| resveratrol 500 | Experimental | In this arm, 64 patients will receive a tablet of 500 mg resveratrol once/day for 6 months Receives: Dietary Supplement: resveratrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
C reactive protein (CRP)
To investigate changes from baseline in blood concentrations of high-sensitivity CRP after six months of treatment with either resveratrol at different dosages or placebo
Measured: up to 25 months
Secondary outcomes (1)
Metabolic and oxidative markers
To evaluate before-after changes in the concentrations of the following: Interleukin 6, Pentraxin-3, total antioxidant status, fasting glucose, insulin, glycated hemoglobin, total and HDL-cholesterol, triglycerides, adiponectin.
Measured: up to 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startOct 2013
- Primary completionFeb 2016
- Study completionFeb 2016
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 Type 2 Diabetes MellitusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Principal investigator, Simona Bo, University of Turin, Italy
- Investigators
- Simona Bo, MD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244879
- Sponsor's protocol ID
- RF-2010-2313155
- Status last verified
- Mar 2016
- First submitted
- 15 Sep 2014
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bo S, Togliatto G, Gambino R, Ponzo V, Lombardo G, Rosato R, Cassader M, Brizzi MF. Impact of sirtuin-1 expression on H3K56 acetylation and oxidative stress: a double-blind randomized controlled trial with resveratrol supplementation. Acta Diabetol. 2018 Apr;55(4):331-340. doi: 10.1007/s00592-017-1097-4. Epub 2018 Jan 12.
PubMed 29330620Bo S, Ponzo V, Evangelista A, Ciccone G, Goitre I, Saba F, Procopio M, Cassader M, Gambino R. Effects of 6 months of resveratrol versus placebo on pentraxin 3 in patients with type 2 diabetes mellitus: a double-blind randomized controlled trial. Acta Diabetol. 2017 May;54(5):499-507. doi: 10.1007/s00592-017-0977-y. Epub 2017 Feb 25.
PubMed 28238190
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resveratrol on Inflammation in Type 2 Diabetic Patients. A Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02244879
- Acronym / sponsor ID
- RF-2010-2313155
- Conditions
- Type 2 Diabetes Mellitus, Inflammation, Insulin Resistance, Other Disorders of Bone Density and Structure
- Keywords
- resveratrol, type 2 diabetes mellitus, inflammation, insulin resistance, body composition, bone mass
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- Oct 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 19 Sep 2014 (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.
This research will investigate the effect of resveratrol on inflammatory mediators in type 2 diabetic patients in vivo.
The investigators will also investigate the hypothesis that resveratrol has an antioxidant activity, improves insulin sensitivity and lipid pattern, down-regulates bone-turnover.
Detailed description
Despite a large body of evidence demonstrating promising effects of resveratrol in rodents, human studies are still lacking and both preventive and therapeutic value of resveratrol in humans remains to be elucidated. The published evidence is not sufficiently strong to recommend for the administration of resveratrol to humans, beyond dietary sources. On the other hand, animal data are promising in prevention of various cancer types, coronary heart diseases and diabetes which strongly indicate the need for human clinical trials.
Furthermore, data are lacking either about safety during long-term administration, or on the efficacy of resveratrol administration in patients with chronic illnesses, such as diabetes mellitus.
The main objective of this study is to investigate the effect of resveratrol on inflammatory mediators in type 2 diabetic patients in vivo.
This research will investigate the hypothesis that resveratrol, when given orally to type 2 diabetic subjects for 24 weeks induces a decrease in values of high-sensitivity CRP (C-reactive protein) (primary outcome measure), IL-6 (Interleukin-6), PTX3 (pentraxin 3).
The investigators will also investigate the hypothesis that resveratrol has an antioxidant activity, improves insulin sensitivity and lipid pattern, down-regulates bone-turnover. Secondary outcomes are therefore variations in the following variables: TAS (total antioxidant status), glycemia, glycated hemoglobin (HbA1c), Homeostasis model assessment of insulin resistance (HOMA-IR), total and HDL-cholesterol, triglycerides, adiponectin, body composition (evaluated by Dual-emission X-ray absorptiometry DXA-), bone mineral density (DXA).
Finally, the investigators are interested in evaluating efficacy, safety and tolerability of two different dosages of resveratrol: 500 mg/day and 40 mg/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: resveratrolIn this arm, 64 patients will receive a tablet of placebo once/day for 6 months |
| resveratrol 40 | Experimental | Dietary Supplement: resveratrolIn this arm, 64 patients will receive a tablet of 40mg resveratrol once/day for 6 months |
| resveratrol 500 | Experimental | Dietary Supplement: resveratrolIn this arm, 64 patients will receive a tablet of 500 mg resveratrol once/day for 6 months |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 35 years of age and older
- Type 2 diabetes with body mass index (BMI)<35 kg/m2
- Subjects on hypoglycemic agents other than insulin
- Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements.
Key exclusion criteria (10 listed)
- Subjects on any antioxidant medication
- Patient on non-steroidal anti-inflammatory drug, steroids or insulin
- On any agent with significant antioxidant properties
- History of drug or alcohol abuse
- Liver or kidney diseases
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 |
|---|---|---|
| resveratrolarm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day | Dietary supplement | placebo, resveratrol 40, resveratrol 500 |
Primary outcome
C reactive protein (CRP)
Time frame: up to 25 months
To investigate changes from baseline in blood concentrations of high-sensitivity CRP after six months of treatment with either resveratrol at different dosages or placebo
1 secondary outcome
Metabolic and oxidative markers
Time frame: up to 25 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 8 Mar 2016.
- Derived from this study: PubMed 29330620Bo S, Togliatto G, Gambino R, Ponzo V, Lombardo G, Rosato R, Cassader M, Brizzi MF. Impact of sirtuin-1 expression on H3K56 acetylation and oxidative stress: a double-blind randomized controlled trial with resveratrol supplementation. Acta Diabetol. 2018 Apr;55(4):331-340. doi: 10.1007/s00592-017-1097-4. Epub 2018 Jan 12.
- Derived from this study: PubMed 28238190Bo S, Ponzo V, Evangelista A, Ciccone G, Goitre I, Saba F, Procopio M, Cassader M, Gambino R. Effects of 6 months of resveratrol versus placebo on pentraxin 3 in patients with type 2 diabetes mellitus: a double-blind randomized controlled trial. Acta Diabetol. 2017 May;54(5):499-507. doi: 10.1007/s00592-017-0977-y. Epub 2017 Feb 25.
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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.
Simona Bo, MD principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing resveratrol in people with Type 2 Diabetes Mellitus and Inflammation, run by University of Turin, Italy at 1 site in Italy.
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 10 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 8 Mar 2016. 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 Italy. 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?
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?
C reactive protein (CRP) (time frame: up to 25 months). 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 NCT02244879, 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 8 Mar 2016.