Type 2 DiabetesNCT01158417
Resveratrol in Type2 Diabetes and Obesity
A study testing Resveratrol 40 mg oral three times a day and Resveratrol 500 mg oral once daily. in people with Type 2 Diabetes and Obesity, run by University at Buffalo at 1 site in United States.
Trial summary
The main objective of this study is to investigate the effect of resveratrol (plant derived food supplement) on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity, Insulin Resistance
- What is being tested?
- Resveratrol 40 mg oral three times a day and Resveratrol 500 mg oral once daily.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to 8 Jul 2012
- Phase
- Interventional
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20 years of age and older
- Healthy Obese subjects with BMI > 30
- Type 2 Diabetics with BMI > 30
- Subjects with good peripheral vein.
- Subjects on statins, ACE inhibitors and thiazolidenediones will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of study.
Who cannot join
- Subjects on any antioxidant medication
- Patient on non-steroidal anti-inflammatory drug
- On any agent with significant antioxidant properties.
- History of drug or alcohol abuse
- Any life threatening disease
- Allergy to peanuts, grapes, wine, mulberries.
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- 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: Effect of Resveratrol on Insulin Resistance and Inflammatory Mediators in Obese and Type 2 Diabetic Subjects
The main objective of this study is to investigate the effect of resveratrol (plant derived food supplement) on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo.
Read the detailed description
The main objective of this study is to investigate the effect of resveratrol on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo. This research will investigate the hypothesis that resveratrol, when given orally to obese and type 2 diabetic subjects induces a decrease in reactive oxygen species (ROS) generation and the pro-inflammatory transcription factor nuclear factor-kB (NF-kB) and the inflammatory mediators regulated by it. The hypothesis that resveratrol suppresses the high fat, high carbohydrate (HFHC) meal induced inflammatory and oxidative response, will also be investigated. This research will also investigate the hypothesis that resveratrol intake for 12 weeks improves insulin sensitivity by lowering the Homeostasis model assessment of insulin resistance (HOMA-IR), an index of insulin resistance and, that resveratrol intake will cause an increase in incretins.
- Conditions
- Type 2 Diabetes, Obesity, Insulin Resistance
- Being tested
- Placebo, Resveratrol 40 mg oral three times a day, Resveratrol 500 mg oral once daily.
- Keywords
- Type 2 Diabetes, Obesity, Insulin Resistance, Resveratrol, Inflammation
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
oral
Resveratrol 40 mg oral three times a dayDrug
Also called Resveratrol 40mg
Drug
Resveratrol 500 mg oral once daily.Drug
Also called Resveratrol 500 mg
Resveratrol 500 mg oral once daily.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo tablets Receives: Drug: Placebo |
| Resveratrol 40 mg oral three times a day | Experimental | Resveratrol Receives: Drug: Resveratrol 40 mg oral three times a day |
| resveratrol 500 mg oral once daily. | Experimental | Resveratrol Receives: Drug: Resveratrol 500 mg oral once daily. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NF-Kb
To investigate the effect of resveratrol on ROS generation and the pro-inflammatory transcription factor NF-kB
Measured: 12 weeks
Secondary outcomes (1)
GLP-1
To see whether Resveratrol leads to a greater stimulation of the incretin system and secretion/release of GIP and GLP-1 when compared to that following placebo
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startDec 2008
- Primary completion8 Jul 2012
- Study completion8 Jul 2012
Why it stopped: FDA clinical hold requiring IND submission, product not available in the market anymore
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Kaleida Health
- Responsible party
- Principal investigator, Paresh Dandona, University at Buffalo
- Investigators
- Paresh Dandona, MD, Principal investigator, Kaleida Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158417
- Sponsor's protocol ID
- 1935
- Status last verified
- Nov 2022
- First submitted
- 7 Jul 2010
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resveratrol on Insulin Resistance and Inflammatory Mediators in Obese and Type 2 Diabetic Subjects
- ClinicalTrials.gov ID
- NCT01158417
- Acronym / sponsor ID
- 1935
- Conditions
- Type 2 Diabetes, Obesity, Insulin Resistance
- Keywords
- Type 2 Diabetes, Obesity, Insulin Resistance, Resveratrol, Inflammation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA clinical hold requiring IND submission, product not available in the market anymore
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Collaborators
- Kaleida Health
- Study start
- Dec 2008 (actual)
- Primary completion
- 8 Jul 2012 (actual)
- Study completion
- 8 Jul 2012 (actual)
- First posted
- 8 Jul 2010 (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 main objective of this study is to investigate the effect of resveratrol (plant derived food supplement) on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo.
Detailed description
The main objective of this study is to investigate the effect of resveratrol on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo. This research will investigate the hypothesis that resveratrol, when given orally to obese and type 2 diabetic subjects induces a decrease in reactive oxygen species (ROS) generation and the pro-inflammatory transcription factor nuclear factor-kB (NF-kB) and the inflammatory mediators regulated by it. The hypothesis that resveratrol suppresses the high fat, high carbohydrate (HFHC) meal induced inflammatory and oxidative response, will also be investigated. This research will also investigate the hypothesis that resveratrol intake for 12 weeks improves insulin sensitivity by lowering the Homeostasis model assessment of insulin resistance (HOMA-IR), an index of insulin resistance and, that resveratrol intake will cause an increase in incretins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets |
| Resveratrol 40 mg oral three times a day | Experimental | Drug: Resveratrol 40 mg oral three times a dayResveratrol |
| resveratrol 500 mg oral once daily. | Experimental | Drug: Resveratrol 500 mg oral once daily.Resveratrol |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 20 years of age and older
- Healthy Obese subjects with BMI > 30
- Type 2 Diabetics with BMI > 30
- Subjects with good peripheral vein.
- Subjects on statins, ACE inhibitors and thiazolidenediones will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of study.
Key exclusion criteria (9 listed)
- Subjects on any antioxidant medication
- Patient on non-steroidal anti-inflammatory drug
- On any agent with significant antioxidant properties.
- History of drug or alcohol abuse
- Any life threatening disease
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 |
|---|---|---|
| Placebooral | Drug | Placebo |
| Resveratrol 40 mg oral three times a dayAlso: Resveratrol 40mgDrug | Drug | Resveratrol 40 mg oral three times a day |
| Resveratrol 500 mg oral once daily.Also: Resveratrol 500 mgResveratrol 500 mg oral once daily. | Drug | resveratrol 500 mg oral once daily. |
Primary outcome
NF-Kb
Time frame: 12 weeks
To investigate the effect of resveratrol on ROS generation and the pro-inflammatory transcription factor NF-kB
1 secondary outcome
GLP-1
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: FDA clinical hold requiring IND submission, product not available in the market anymore). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
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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.
Paresh Dandona, MD principal investigator
Kaleida Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resveratrol 40 mg oral three times a day and Resveratrol 500 mg oral once daily. in people with Type 2 Diabetes and Obesity, run by University at Buffalo at 1 site in United States.
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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 9 Nov 2022. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: FDA clinical hold requiring IND submission, product not available in the market anymore). Results are not available in the source record.
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?
NF-Kb (time frame: 12 weeks). 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 9 Nov 2022.