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

Completed

Conditions: Metabolic syndrome
obesity
10018424
10000546

Registration Number: NL-OMON42899

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

Patients: Male obese (BMI > 30) subjects 21 to 65 years-old
With at least 3 out of 5 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). ;Donors: caucasian, age 18 - 65 years old, BMI 18.5 - 25 kg/m2

Exclusion Criteria

Patients:
- 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;Exclusion criteria for donors:
1. diarrhoea
2. cholecystectomy
3. HIV, HAV, HBV, HCV, active CMV, active EBV
4. Unsafe sex practice (questionnaire)
5. presence of fecal bacterial pathogens (salmonella, Shigella, Campylobacter, Yersinia) or parasites
6. positive C. difficile stool test
7. any medication use including PPI and antibiotics;Individuals with an increased risk for one of the above conditions (homosexual contacts, recent blood transfusions) will be excluded, and donors are not recruited amongst health care providers.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints are changes in fecal, intestinal (biopsies) and oral<br /><br>microbiota composition and (the relation to) peripheral /hepatic insulin<br /><br>sensitivity (stable isotope based hyperinsulinemic euglycemic clamp and resting<br /><br>energy expenditure) at baseline and 6 weeks. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are changes in postprandial plasma lipids (mixed meal test)<br /><br>and subcutaneous adipose tissue inflammation (biopt) at baseline and 6 weeks.<br /><br>Finally, we will study effect on plasma and 24 feces and 24 urine metabolites<br /><br>at baseline, after 3 and 6 weeks</p><br>