Pre-diabetesNCT02129595
Resveratrol and First-degree Relatives of Type 2 Diabetic Patients
A study testing resveratrol in people with Pre-diabetes, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The main objective of the study is to investigate if resveratrol supplementation can improve overall and muscle-specific insulin sensitivity in first-degree relatives of type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Pre-diabetes
- 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
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2014to 31 Jul 2017
- 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 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male sex
- Age: 40-70 years
- BMI 27-35 kg/m2
- Has first-degree relative(s) diagnosed with type 2 diabetes
- Sedentary
- Not more than 2 hours of sports a week
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- No active job that requires strenuous physical activity
- Stable dietary habits: no weight gain or loss > 5kg in the last three months
- Insulin resistant: glucose clearance rate below < 350 ml/kg/min, as determined using OGIS120
- Willingness to abstain from resveratrol-containing food products
- Subjects will only be included when the dependent medical doctor of this study approves participation after evaluating data obtained during screening
Who cannot join
- Use of anticoagulants
- Uncontrolled hypertension
- Haemoglobin <7.8 mmol/l
- In case of an abnormal ECG in rest: this will be discussed with the responsible medical doctor
- HBA1C > 6.5%
- Diagnosed with type 2 diabetes
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- Medication use known to interfere with glucose homeostasis/metabolism
- Current alcohol consumption > 20 grams/day
- Subjects who don't want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed, cannot participate in the study.
- Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the intervention.
- Participation in another biomedical study within 1 month before the first screening visit
- Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk
- Any contra-indication to MRI scanning. These contra-indications include patients with following devices:
- Central nervous system aneurysm clip
- Implanted neural stimulator
- Implanted cardiac pacemaker of defibrillator
- Cochlear implant
- Insulin pump
- Metal containing corpora aliena in the eye or brains
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6200 MD
About this study
Official title: Effects of Resveratrol on Insulin Sensitivity, Brown Adipose Tissue and Metabolic Profile in First-degree Relatives of Type 2 Diabetic Patients
The main objective of the study is to investigate if resveratrol supplementation can improve overall and muscle-specific insulin sensitivity in first-degree relatives of type 2 diabetic patients.
As a secondary objective the investigators want to investigate whether the improved insulin sensitivity can be attributed to improved muscle mitochondrial oxidative capacity and a reduced intrahepatic and cardiac lipid content. Furthermore, in a subset of the participants the investigators want to investigate the effect of resveratrol on glucose uptake in brown adipose tissue.
- Conditions
- Pre-diabetes
- Being tested
- placebo, resveratrol
- Keywords
- Resveratrol, Diabetes Mellitus, Diabetes Mellitus, Type 2, Insulin Resistance, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Hyperinsulinism, Anti-Inflammatory Agents, Non-Steroidal, Analgesics, Non-Narcotic, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Pharmacologic Actions, Anti-Inflammatory Agents, Therapeutic Uses, Antirheumatic Agents, Antineoplastic Agents, Phytogenic, Antineoplastic Agents
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Diabetes Mellitus, Type 2, Insulin Resistance, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDietary supplement
A placebo will given for 30 days or 34 days (if included in brown adipose tissue measurement), twice daily. One pill will be provided with lunch, and the other pill will be provided with dinner.
resveratrolDietary supplement
Also called resVida (99% pure trans-resveratrol)
resveratrol will be given for 30 days or 34 days (if included in brown adipose tissue measurement), twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill, also containing 75 mg will be given with dinner. So in total a dose of 150 mg/day will be given.
| Study group | Role | What they receive |
|---|---|---|
| resveratrol | Active comparator | resveratrol will be given for 30 or 34 days (if included in brown adipose tissue measurement), twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill of 75 mg will be provided with dinner. So in total 150 mg/day of resveratrol will be given. Receives: Dietary Supplement: resveratrol |
| placebo | Placebo comparator | A placebo will be given for 30 or 34 days (if included in brown adipose tissue measurement), twice daily. One pill will be provided with lunch and the other pill will be provided with dinner. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity: overall, muscle- and liver specific
Hyperinsulinemic euglycemic clamp combined with indirect calorimetry: Glucose infusion rate (GIR), rate of appearance and disappearance of glucose (Ra, Rd), endogenous glucose production (EGP), oxidative and non-oxidative glucose disposal, carbohydrate and lipid oxidation, energy expenditure.
Measured: 30 days after supplementation
Secondary outcomes (6)
muscle mitochondrial oxidative capacity (in vivo and ex vivo)
In vivo: Phosphocreatine levels will be measured by P-MRS (before, during, and after exercise) as a marker for in vivo mitochondrial function in the vastus lateralis muscle.
Ex vivo mitochondrial function in skeletal muscle will be measured by oxygen consumption in muscle fibres (muscle biopsy) on lipid-derived and carbohydrate-derived substrates.
Measured: 30 days after supplementation
intramyocellular lipid content
Skeletal muscle lipid accumulation measured by immunohistochemistry in muscle biopsy from vastus lateralis muscle
Measured: 30 days after supplementation
intrahepatic lipid content
Intrahepatic lipid content measured with H-MRS
Measured: 30 days after supplementation
intracardiac lipid content
Intracardiac lipid content measured with H-MRS
Measured: 30 days after supplementation
heart function
Cardiac function: diastolic and systolic heart function will be measured with ultrasound
Measured: 30 days after supplementation
brown adipose tissue activity
subjects will be exposed to an individualized cooling protocol, after which an 18F-FDG PET/CT scan is made
Measured: 34 days after supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG, Diabetes Fonds
- Responsible party
- Sponsor
- Investigators
- Patrick Schrauwen, PhD, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129595
- Sponsor's protocol ID
- 13-3-058
- Status last verified
- Aug 2016
- First submitted
- 24 Apr 2014
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
de Ligt M, Bruls YMH, Hansen J, Habets MF, Havekes B, Nascimento EBM, Moonen-Kornips E, Schaart G, Schrauwen-Hinderling VB, van Marken Lichtenbelt W, Schrauwen P. Resveratrol improves ex vivo mitochondrial function but does not affect insulin sensitivity or brown adipose tissue in first degree relatives of patients with type 2 diabetes. Mol Metab. 2018 Jun;12:39-47. doi: 10.1016/j.molmet.2018.04.004. Epub 2018 Apr 18.
PubMed 29706321
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resveratrol on Insulin Sensitivity, Brown Adipose Tissue and Metabolic Profile in First-degree Relatives of Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02129595
- Acronym / sponsor ID
- 13-3-058
- Conditions
- Pre-diabetes
- Keywords
- Resveratrol, Diabetes Mellitus, Diabetes Mellitus, Type 2, Insulin Resistance, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Hyperinsulinism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG, Diabetes Fonds
- Study start
- Apr 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 2 May 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.
The main objective of the study is to investigate if resveratrol supplementation can improve overall and muscle-specific insulin sensitivity in first-degree relatives of type 2 diabetic patients.
As a secondary objective the investigators want to investigate whether the improved insulin sensitivity can be attributed to improved muscle mitochondrial oxidative capacity and a reduced intrahepatic and cardiac lipid content. Furthermore, in a subset of the participants the investigators want to investigate the effect of resveratrol on glucose uptake in brown adipose tissue.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resveratrol | Active comparator | Dietary Supplement: resveratrolresveratrol will be given for 30 or 34 days (if included in brown adipose tissue measurement), twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill of 75 mg will be provided with dinner. So in total 150 mg/day of resveratrol will be given. |
| placebo | Placebo comparator | Dietary Supplement: placeboA placebo will be given for 30 or 34 days (if included in brown adipose tissue measurement), twice daily. One pill will be provided with lunch and the other pill will be provided with dinner. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male sex
- Age: 40-70 years
- BMI 27-35 kg/m2
- Has first-degree relative(s) diagnosed with type 2 diabetes
- Sedentary
Key exclusion criteria (19 listed)
- Use of anticoagulants
- Uncontrolled hypertension
- Haemoglobin <7.8 mmol/l
- In case of an abnormal ECG in rest: this will be discussed with the responsible medical doctor
- HBA1C > 6.5%
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 |
|---|---|---|
| placeboA placebo will given for 30 days or 34 days (if included in brown adipose tissue measurement), twice daily. One pill will be provided with lunch, and the other pill will be provided with dinner. | Dietary supplement | placebo |
| resveratrolAlso: resVida (99% pure trans-resveratrol)resveratrol will be given for 30 days or 34 days (if included in brown adipose tissue measurement), twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill, also containing 75 mg will be given with dinner. So in total a dose of 150 mg/day will be given. | Dietary supplement | resveratrol |
Primary outcome
insulin sensitivity: overall, muscle- and liver specific
Time frame: 30 days after supplementation
Hyperinsulinemic euglycemic clamp combined with indirect calorimetry: Glucose infusion rate (GIR), rate of appearance and disappearance of glucose (Ra, Rd), endogenous glucose production (EGP), oxidative and non-oxidative glucose disposal, carbohydrate and lipid oxidation, energy expenditure.
6 secondary outcomes
muscle mitochondrial oxidative capacity (in vivo and ex vivo)
Time frame: 30 days after supplementation
intramyocellular lipid content
Time frame: 30 days after supplementation
intrahepatic lipid content
Time frame: 30 days after supplementation
intracardiac lipid content
Time frame: 30 days after supplementation
heart function
Time frame: 30 days after supplementation
brown adipose tissue activity
Time frame: 34 days after supplementation
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 Aug 2017.
- Derived from this study: PubMed 29706321de Ligt M, Bruls YMH, Hansen J, Habets MF, Havekes B, Nascimento EBM, Moonen-Kornips E, Schaart G, Schrauwen-Hinderling VB, van Marken Lichtenbelt W, Schrauwen P. Resveratrol improves ex vivo mitochondrial function but does not affect insulin sensitivity or brown adipose tissue in first degree relatives of patients with type 2 diabetes. Mol Metab. 2018 Jun;12:39-47. doi: 10.1016/j.molmet.2018.04.004. Epub 2018 Apr 18.
- 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.
Patrick Schrauwen, PhD principal investigator
Maastricht University Medical Centre
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 in people with Pre-diabetes, run by Maastricht University Medical Center at 1 site in Netherlands.
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 11 inclusion and 19 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 Aug 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 Netherlands. 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 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?
insulin sensitivity: overall, muscle- and liver specific (time frame: 30 days after supplementation). 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 NCT02129595, which also lists 1 linked publication.
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 Aug 2017.