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| Name | Class |
|---|---|
| dsm-firmenich Switzerland AG | INDUSTRY |
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The main objective of the study is to investigate if resveratrol supplementation can improve overall and muscle-specific insulin sensitivity in 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | A placebo will be given for 30 days, twice daily. One pill will be provided with lunch and the other pill will be provided with dinner. |
|
| resveratrol | Active Comparator | resveratrol will be given for 30 days, 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Dietary Supplement | A placebo will given for 30 days, twice daily. One pill will be provided with lunch, and the other pill will be provided with dinner. |
|
| Measure | Description | Time Frame |
|---|---|---|
| insulin sensitivity (overall, muscle- and liver specific) | 30 days after supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| muscle mitochondrial oxidative capacity | 30 days after supplementation | |
| intramyocellular lipid content | 30 days after supplementation | |
| intrahepatic lipid content |
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Inclusion Criteria:
Male sex
Age: 40-70 years
Body fat percentage > 25, BMI 27-35 kg/m2
Diagnosed with type 2 diabetes at least one year before the start of the study
Well-controlled type 2 diabetics: HBA1C < 8.0%
Oral glucose lowering medication (metformin only or in combination with sulfonylurea agents)
Sedentary
Stable dietary habits
Willingness to abstain from resveratrol-containing food products
Exclusion Criteria:
Unstable body weight (weight gain or loss > 3kg in the last three months)
Total body fat percentage < 25%
Hemoglobin < 7.8 mmol/l
Use of anticoagulants
Engagement in programmed exercise > 2 hours total per week
Impaired kidney and/or hepatic function Creatinine 50-100 umol/L Liver enzymes, within 2 times of normal range of laboratory standard (ASAT < 60 U/L, ALAT < 70 U/L, Billi <40 umol/L, gamma-GT < 80 U/L)
No diabetes related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, retinopathy
Insulin dependent Diabetic subjects
Any medical condition except type 2 diabetes mellitus requiring treatment and/or medication use except metformin only or in combination with sulfonylurea agents
Intake of dietary supplements except multivitamins and minerals
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.
Participation in another biomedical study within 1 month before the first screening visit
Any contraindication to MRI scanning. These contra-indications include patients with following devices:
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| Name | Affiliation | Role |
|---|---|---|
| Silvie Timmers, PhD | Human Biology, Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6200MD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22055504 | Background | Timmers S, Konings E, Bilet L, Houtkooper RH, van de Weijer T, Goossens GH, Hoeks J, van der Krieken S, Ryu D, Kersten S, Moonen-Kornips E, Hesselink MKC, Kunz I, Schrauwen-Hinderling VB, Blaak E, Auwerx J, Schrauwen P. Calorie restriction-like effects of 30 days of resveratrol supplementation on energy metabolism and metabolic profile in obese humans. Cell Metab. 2011 Nov 2;14(5):612-22. doi: 10.1016/j.cmet.2011.10.002. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| D036881 | Long-Term Synaptic Depression |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| resveratrol | Dietary Supplement | resveratrol will be given for 30 days, 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. |
|
|
| 30 days after supplementation |
| intracardiac lipid content | 30 days after supplementation |
| heart function | 30 days after supplementation |
| D004700 | Endocrine System Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |