Metabolic Syndrome
Conditions
Brief summary
Obesity is associated with changes in the composition and metabolic function of the gut microbiota. Fecal microbiota transplantation (FMT), also known as fecal bacteriotherapy or fecal infusion, refers to the process of injecting a liquid suspension of stool from a healthy donor into the gastrointestinal (GI) tract of a patient to cure a specific disease. However, since the recently established concept of human gut microbiome and its significant role in health and disease has caught on in the medical scientific world, this procedure has gained a great pathophysiological strength, meaning not only the simple infusion of stools, but the transplantation of a healthy gut microbiota in a patient with a disrupted one. In a recent dutch experience, FMT from lean donors was able to increase the insulin sensitivity in patients with metabolic syndrome. Our primary aim is to evaluate if FMT from lean healthy donors, in association to lifestyle changes, is able to reduce insulin-resistance more than lifestyle changes alone in patients with metabolic syndrome. All the patients with metabolic syndrome will receive lifestyle counselling (1400 kilocalories diet and physical activity encouragement), than will be randomized to FMT from healthy lean donors by upper endoscopy (group A) or no treatment (group B)
Interventions
OTHERfecal microbiota transplantation from healthy lean donors
fecal microbiota transplantation from healthy lean donors
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Both males and females between 30 and 60 years old * BMI\>30 and \>35 kg/m2 * Diagnosis of Metabolic Syndrome according to National Cholesterol Education Program's Adult Treatment Panel III criteria * No ongoing therapy for diabetes, hyperlipidemia or arterial hypertension * Signature of written informed consent
Exclusion criteria
* recent (3 months) use of probiotic, antibiotics or other drugs * Increase in triglycerides levels, (≥ 300 mg/dl), LDL levels (≥ 190 mg/dl, or modification of body weight (±5%) during the last 3 months * Relevant cardiovascular diseases or kidney diseases * Relevant gastrointestinal diseases (such as inflammatory bowel disease or celiac disease) * Former gastrointestinal surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| difference in euglycemic clamp value at baseline and after the treatment | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Disappearance of metabolic syndrome | 6 months |
| Modification in fasting blood glucose | 6 months |
| Modification in serum triglycerides | 6 months |
| Modification in serum High Density Lipoprotein cholesterol | 6 months |
| Modification in flow-mediated dilatation (FMD) of the brachial artery | 6 months |
| Modification in abdominal circumference | 6 months |
| Modification in serum Tumor Necrosis Factor-alpha | 6 months |
| Modification in serum C-Reactive Protein | 6 months |
| Modification in serum interleukin-6 | 6 months |
| Modification in blood pressure | 6 months |
Countries
Italy
Outcome results
None listed