Effects of butyrate compared to donor faeces transplantation on metabolism and satiety in patients with metabolic syndrome

Completed

Conditions: gut microbiota
metabolic syndrome
10018424

Registration Number: NL-OMON41779

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 36

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 (m) / > 88 cm (f), HDL-cholesterol * 1.04 mmol/l (m) / * 1.30 mmol/l (f), blood pressure * 130/85 mmHg

Exclusion Criteria

- Medication use, including PPI and antibiotics in last 3 months
- Smoking, XTC, amphetamine or cocaine abuse
- Alcohol abuse (>3/day)
- Participation in a research protocol involving radiation exposure in the last 2 years.
- eGFR <60 ml/min
- Contraindication MRI
- 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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Differences in insulin sensitivity and lipolysis (including lipid content in<br /><br>muscle biopsies), as measured by a hyperinsulinemic euglycemic clamp and<br /><br>satiety as measured by validated eating behaviour questionnaires in combination<br /><br>with cerebral binding of the radioligand [123I]FP-CIT to serotonin transporters<br /><br>(as visualised by SPECT-scan) related to small intestinal serotonin levels in<br /><br>small intestinal biopsies. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Changes in faecal and small intestinal microbiota composition in relation to<br /><br>faecal energy excretion (24h faeces), resting and physical activity<br /><br>(accelerometers) intestinal permeability (faecal calprotectin levels),<br /><br>intestinal passage time (Sitzmark capsules), sympathetic tone (Nexfin) and<br /><br>plasma markers of low grade inflammation (LPS), glucose and lipid metabolism<br /><br>(proteomics), liver fat (MRI).</p><br>