Fecal microbiota transplantation for improved Fructose catabolism and Insulin sensiTivity In patients with metabolic syndrome : the FFIT study

Recruiting

Conditions: insulin resistance/Dm2
microbiota
10018424

Registration Number: NL-OMON49935

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 56

Inclusion Criteria

patients:
-treatment naive metabolic syndrome/insulin resistant subjects
-surinamese asian or caucasian ethnicity
- male/postmenopauzal female
- age 40-65 years

donors:
-healthy (no medication use)
- enriched gutmicrobiota desulfovibrio levels

Exclusion Criteria

-unable to provide written informed consent-
- antibiotics / PPI-antacids use in the last 3 months
- nicotine/alcohol abuse

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcomes are changes in periperhal insulin sensitivity(as determined by<br /><br>stable isotope (6-6-D2) based hyperinsulinemic clamp for calculation of<br /><br>endogenous hepatic glucose prodution). Also, changes in glucose excursions as<br /><br>detrmined by FreeStyle Libre sensors in relation to changes in (oral , small<br /><br>intestinal and fecal) gut microbiota diversity and composition at baseline<br /><br>and after 6 weeks of FMT.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are changes in post fructose (13c stable isotope)<br /><br>challenge enrichment of metabolites including alcohol in plasma, 24h urine ,<br /><br>24h feces as well as changes in small intestinal fructose receptor expression<br /><br>and fructose oxidation in exhaled air at these timepoints.Other secondary<br /><br>outcomes comprise changes in MRI imaging of hepatic fat content measured<br /><br>before and after FMT as well as changes in fecal and plasma SCFA and bileacid<br /><br>levels.</p><br>