- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Limburg
-
Maastricht, Limburg, Nederländerna, 6200MD
- Maastricht University Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: 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.
|
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.
|
|
Aktiv komparator: 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.
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
insulin sensitivity (overall, muscle- and liver specific)
Tidsram: 30 days after supplementation
|
30 days after supplementation
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
muscle mitochondrial oxidative capacity
Tidsram: 30 days after supplementation
|
30 days after supplementation
|
|
intramyocellular lipid content
Tidsram: 30 days after supplementation
|
30 days after supplementation
|
|
intrahepatic lipid content
Tidsram: 30 days after supplementation
|
30 days after supplementation
|
|
intracardiac lipid content
Tidsram: 30 days after supplementation
|
30 days after supplementation
|
|
heart function
Tidsram: 30 days after supplementation
|
30 days after supplementation
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Silvie Timmers, PhD, Human Biology, Maastricht University Medical Center
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 11-3-092
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