Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42899
Enrollment
36
Registered
2017-02-21
Start date
2016-10-31
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome obesity

Interventions

All patient will adhere to the mediterranean for the total duration of the study with guidance of a dietitian and/or investigator. Patients will be treated with infusion of either allogenic (lean he
during the procedure mucosal biopsies from small intestine will be taken. Correct position of the tube is checked with an abdominal X-ray. 3. Thereafter, bowel lavage with 2-3 liters of Clean Prep th
Gut microbiota
Mediterranean diet

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Secondary endpoints are changes in postprandial plasma lipids (mixed meal test) and subcutaneous adipose tissue inflammation (biopt) at baseline and 6 weeks. Finally, we will study effect on plasma and 24 feces and 24 urine metabolites at baseline, after 3 and 6 weeks

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)