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Effects of butyrAte comPared to donor faeces transPlantation on mETabolIsm and saTiEty in patients with metabolic syndrome


- candidate number19229
- NTR NumberNTR4713
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-aug-2014
- Secondary IDsMEC 14/084 
- Public TitleEffects of butyrAte comPared to donor faeces transPlantation on mETabolIsm and saTiEty in patients with metabolic syndrome
- Scientific TitleEffects of butyrAte comPared to donor faeces transPlantation on mETabolIsm and saTiEty in patients with metabolic syndrome
- ACRONYMAPPETITE study
- hypothesisIntestinal bacteria have been linked to human metabolism. Animal studies have suggested that the intestinal microbiota product butyrate itself can also affect satiety and improves insulin sensitivity. The question thus remains whether increasing intestinal levels of butyrate itself has the same metabolic effects as increasing levels of intestinal butyrate-producing bacterial strains. We therefore aim to compare the effects of oral butyrate vs donor fecal transplantation on insulin sensitivity, intestinal transit time and serotonin mediated satiety in treatment naive patients with insulin resistance.
- Healt Condition(s) or Problem(s) studiedInsulin resistance, Obesity, Metabolic syndrome, Gut microbiota
- Inclusion criteria- Caucasian male or postmenopausal female
- 50-70 years old
- BMI ≥30 kg/m2
- At least 3 out of 5 NCEP metabolic syndrome criteria: fasting plasma glucose ≥ 5.6 mmol/l, triglycerides ≥ 1.7 mmol/l, waist-circumference > 102 cm, HDL-cholesterol 1.04 mmol/l, blood pressure ≥ 130/85 mmHg
- Subjects should be able and willing to give informed consent
- Exclusion criteria-Any Medication use, including PPI and antibiotics in last 3 months
- Drug abuse
- Alcohol abuse (>3/day)
- Participation in a research protocol involving radiation exposure in the last 2 years.
- eGFR <60 ml/min
- Contraindication for MRI (claustrophobia)
- History of cardiovascular event (MI or pacemaker implantation)
- Cholecystectomy
- Expected prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count < 240)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate1-mrt-2017
- Target number of participants24
- Interventionsallogenic healthy (postbariatric surgery) donor feces transplantation + placebo tablets for 4 weeks VERSUS autologous fecal transplantation + sodium butyrate tablets for 4 weeks
- Primary outcome- Insulin sensitivity and lipolysis (2-step hyperinsulinemic euglycemic clamp)
- Hypothalamic (SPECT-scan), small intestinal (biopsy) and urinal (24h urine sample) serotonin levels in relation to satiety testing
- Secondary outcome- Faecal energy excretion and short chain fatty acid and bile acid concentration in feces
- Dietary intake (dietary lists), resting energy expenditure (calorimetry) and physical activity energy expenditure (accelerometers)
- Faecal and small intestinal gut microbiota composition (morning stool samples and biopsies)
- Intestinal permeability (faecal calprotectin levels)
- Intestinal passage time (Sitzmark capsules)
- Sympathetic tone (Nexfin)
- Inflammatory and lipid-proteomic markers (blood samples)
- Liver fat for NAFLD/NASH degree (MRI)
- 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)
EU FP 7
- Publications
- Brief summaryIn this RCT we aim to dissect whether intestinal microbiota or their product butyrate affect human (serotonin) driven satiety and insulin resistance in humans.
- Main changes (audit trail)
- RECORD1-aug-2014 - 24-mei-2017


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