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Effect of Fecal microbiotA Transplantation combined with MEditerranean Diet on insulin sensitivity in subjects with metabolic syndrome


- candidate number24675
- NTR NumberNTR5983
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jul-2016
- Secondary IDsMETC 2016_117 
- Public TitleEffect of Fecal microbiotA Transplantation combined with MEditerranean Diet on insulin sensitivity in subjects with metabolic syndrome
- Scientific TitleEffect of Fecal microbiotA Transplantation combined with MEditerranean Diet on insulin sensitivity in subjects with metabolic syndrome
- ACRONYMFATMED trial
- hypothesisTo study if a Mediterranean diet (MD) followed by lean donor fecal microbiota transplantation (FMT) has synergistic superior beneficial effects on peripheral insulin sensitivity and (small) intestinal microbiota composition as compared to prescription of Mediterranean diet (MD) followed by autologous (own) FMT in male subjects with metabolic syndrome.
- Healt Condition(s) or Problem(s) studiedMetabolic syndrome, Insulin resistance, Diet
- Inclusion criteria-Male obese subjects with metabolic syndrome
-21 to 65 years-old
-body mass index (BMI) 30 to 43 kg/m2)
-3 out of 5 NCEP metabolic syndrome criteria (fasting plasma glucose 6.1 mmol/l, triglycerides 1.7 mmol/l, waist-circumference > 102 cm, HDL-cholesterol < 1.04 mmol/l, blood pressure 130/85 mmHg)
- Exclusion criteria - Use of any medication, including proton pomp inhibitors and antibiotics in the past three months
- Cholecystectomy
- A history of cardiovascular event (MI or pacemaker implantation)
- (expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count < 240).
- Unmotivated or not able to adhere to a specific diet.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2016
- planned closingdate31-jul-2018
- Target number of participants24
- Interventionsfecal transplantation (allogeneic/lean donor or autologous) on top of mediterranean diet
- Primary outcomeEffect of mediterranean diet followed by lean donor FMT versus mediterranean diet followed by autologous FMT on intestinal microbiota composition at 0,3,6, and 12 weeks .
- Secondary outcomechanges in insulin sensitivity (hyperinsulinemic clamp) at baseline and after 6 weeks
Secundary objective:
- Changes in postprandial plasma glucose and incretins (mixed meal test) at baseline and 6 weeks
- Changes in subcutaneous adipose tissue inflammation (Subcutaneous adipose tissue biopsy) at baseline and 6 weeks
- Changes in 24h fecal and urine metabolites (feces and urine samples)
- Timepoints0.6 weeks
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. M. Nieuwdorp
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M. Nieuwdorp
- Sponsor/Initiator ZonMw: The Netherlands Organization for Health Research and Development
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryPrevious research has shown that faecal microbiota transplantation of lean healthy donors improves insulin sensitivity (Vrieze et al., 2012) and recent data have suggested that engraftment of beneficial lean donor bacterial differs between metabolic syndrome subjects (Li-Nieuwdorp, Science 2016). Since diet is thought to be of pivotal importance in stabilizing gutmicrobiota composition (David et al., 2014; De Filippis et al., 2015) we hypothesize that prescription of a healthy (Mediterranean) diet before lean donor fecal transplantation will allow enhanced engraftment of beneficial bacteria in the intestine of metabolic syndrome subject and will have a synergistic beneficial effect on peripheral insulin sensitivity.
- Main changes (audit trail)
- RECORD21-jul-2016 - 26-sep-2016


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