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Het effect van een hoog-vet dieet op galzouten in het bloed.


- candidate number24320
- NTR NumberNTR5848
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-mei-2016
- Secondary IDsNL41901.018.12 
- Public TitleHet effect van een hoog-vet dieet op galzouten in het bloed.
- Scientific TitleThe effect of a high-fat diet on postprandial bile acid responses in obese subjects
- ACRONYMBAM2
- hypothesisBile acids are pleiotropic hormones with actions on energy expenditure and insulin sensitivity in animal models. A high-fat diet that affects insulin sensitivity could modulate postprandial bile acid concentrations in plasma, leading to downstream effects on insulin sensitivity through its receptors FXR and TGR5.
- Healt Condition(s) or Problem(s) studiedObesity, Diabetes Mellitus Type 2 (DM type II)
- Inclusion criteriaBMI > 30
HOMA IR index < 2.7
- Exclusion criteriaDiabetes Mellitus
Medication use
History of gastrointetinal surgery
History of metabolic disease
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 11-jun-2013
- planned closingdate
- Target number of participants12
- InterventionsHigh fat eucaloric diet (>90 energy% from fats)
- Primary outcomepostprandial bile acid concentrations in plasma
- Secondary outcomepostprandial insulin and glucose concentrations in plasma, resting energy expenditure
- Timepoints0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 240
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. M.R. Soeters
- CONTACT for SCIENTIFIC QUERIESMD. M.R. Soeters
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Diabetes Fonds
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD4-mei-2016 - 1-jul-2016


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