metabolic syndrome insulin resistance microbiota mediterranean diet
Conditions
Interventions
fecal transplantation (allogeneic/lean donor or autologous) on top of mediterranean diet
Sponsors
ZONMW
Eligibility
Inclusion criteria
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 ¡Ý 6.1 mmol/l, triglycerides ¡Ý 1.7 mmol/l, waist-circumference > 102 cm, HDL-cholesterol < 1.04 mmol/l, blood pressure ¡Ý 130/85 mmHg)
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect 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
| Measure | Time frame |
|---|---|
| changes 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) | — |
Contacts
Public ContactM. Nieuwdorp
AFDELING INWENDIGE GENEESKUNDE AMC MEIBERGDREEF 9, KAMER F4.159.2
Outcome results
None listed