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The effect of Oral BUtyrate on human Glucose and brownfAT metabolism: The OBUGAT study


- candidate number16015
- NTR NumberNTR4392
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jan-2014
- Secondary IDsMEC 13/239 
- Public TitleThe effect of Oral BUtyrate on human Glucose and brownfAT metabolism: The OBUGAT study
- Scientific TitleThe effect of Oral BUtyrate on human Glucose and brownfAT metabolism: The OBUGAT study
- ACRONYMOBUGAT study
- hypothesisBrown adipose tissue (BAT) is thought to be involved in human glucose and lipid metabolism, however the mechanisms by which this adipose tissue is activated remain to be elucidated. Recent data in db/db mice have suggested that oral butyrate has effect on glucose metabolism and BAT activation. We will now investigate the effect of oral sodium butyrate daily during 4 weeks in both healthy lean and obese, insulin resistant male subjects (matched for age) on insulin sensitivity and BAT activation.
- Healt Condition(s) or Problem(s) studiedInsulin sensitivy, Brown adipose tissue
- Inclusion criteria Healthy lean male volunteers (N=10, BMI 19-25 kg/m2) and obese insulin resistant male volunteers (N=10) matched for age will be recruited and tested for BAT activity and insulin sensitivity before and after oral butyrate treatment.
- Exclusion criteria- Any Medication or probiotic use - Smoking - Participation in a research protocol involving radiation exposure in the last 2 years. - eGFR <60 ml/min
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 14-jan-2014
- planned closingdate31-dec-2015
- Target number of participants20
- InterventionsIntervention: Patients will be treated with sodiumbutyrate orally once daily during 4 weeks
- Primary outcome Primary objective: To investigate whether butyrate influences the metabolic activity of BAT (as assessed with a FDG-PET CT scan) in relation to hepatic and peripheral insulin sensitivity (two step hyperinsulinemic normoglycemic clamp).
- Secondary outcomeSecondary Objectives: -To determine whether differences in resting energy expenditure during thermoneutral conditions correlate with the metabolic BAT activity before and after butyrate treatment. - To determine if fecal gutmicrobiota and fecal energy excretion are altered upon oral butyrate treatment. -Changes in expression of genes involved in insulin phosphorylation signalling pathways, inflammation and lipid synthesis in subcutaneous fat upon oral butyrate supplementation. - changes in plasma (monocyte) and subcutaneous adipose tissue inflammatory markers upon 4 weeks of butyrate treatment.
- Timepoints0 and 4 weeks
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. PhD. M. Nieuwdorp
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M. Nieuwdorp
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam, University of Amsterdam (UvA)
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), University of Amsterdam
- Publications
- Brief summaryWe aim to investigate the effect of oral butyrate on insulin sensitivity and brown fat activation in both lean male subjects and obese insulin resistant subjects matched for age.
- Main changes (audit trail)
- RECORD9-jan-2014 - 24-mei-2017


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