- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01638780
Resveratrol and Type 2 Diabetes
Effect of Resveratrol on Insulin Sensitivity and Metabolic Profile in Type 2 Diabetics
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Limburg
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Maastricht, Limburg, Pays-Bas, 6200MD
- Maastricht University Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
- Not more than 2 hours of sports a week
- No active job that requires strenuous physical activity
- 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:
- Central nervous system aneurysm clip
- Implanted neural stimulator
- Implanted cardiac pacemaker of defibrillator
- Cochlear implant
- Insulin pump
- Or metal containing corpora aliena in the eye or brains
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: placebo
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.
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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.
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Comparateur actif: resveratrol
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.
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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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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insulin sensitivity (overall, muscle- and liver specific)
Délai: 30 days after supplementation
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30 days after supplementation
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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muscle mitochondrial oxidative capacity
Délai: 30 days after supplementation
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30 days after supplementation
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intramyocellular lipid content
Délai: 30 days after supplementation
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30 days after supplementation
|
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intrahepatic lipid content
Délai: 30 days after supplementation
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30 days after supplementation
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intracardiac lipid content
Délai: 30 days after supplementation
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30 days after supplementation
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heart function
Délai: 30 days after supplementation
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30 days after supplementation
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Silvie Timmers, PhD, Human Biology, Maastricht University Medical Center
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Troubles du métabolisme du glucose
- Maladies métaboliques
- Maladies du système endocrinien
- Diabète sucré
- Diabète sucré, Type 2
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Inhibiteurs de l'agrégation plaquettaire
- Agents protecteurs
- Antioxydants
- Resvératrol
Autres numéros d'identification d'étude
- 11-3-092
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