No registrations found.
ID
Source
Brief title
Health condition
insulin resistance, overweight, gutmicrobiota
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Insulin sensitivity and lipolysis (2-step hyperinsulinemic euglycemic clamp)
- Hypothalamic (SPECT-scan), small intestinal (biopsy) and urinal (24h urine sample) serotonin levels in relation to satiety testing
Secondary outcome
- Faecal energy excretion and short chain fatty acid and bile acid concentration in feces
- Dietary intake (dietary lists), resting energy expenditure (calorimetry) and physical activity energy expenditure (accelerometers)
- Faecal and small intestinal gut microbiota composition (morning stool samples and biopsies)
- Intestinal permeability (faecal calprotectin levels)
- Intestinal passage time (Sitzmark capsules)
- Sympathetic tone (Nexfin)
- Inflammatory and lipid-proteomic markers (blood samples)
- Liver fat for NAFLD/NASH degree (MRI)
Background summary
In this RCT we aim to dissect whether intestinal microbiota or their product butyrate affect human (serotonin) driven satiety and insulin resistance in humans.
Study objective
Intestinal bacteria have been linked to human metabolism. Animal studies have suggested that the intestinal microbiota product butyrate itself can also affect satiety and improves insulin sensitivity. The question thus remains whether increasing intestinal levels of butyrate itself has the same metabolic effects as increasing levels of intestinal butyrate-producing bacterial strains. We therefore aim to compare the effects of oral butyrate vs donor fecal transplantation on insulin sensitivity, intestinal transit time and serotonin mediated satiety in treatment naive patients with insulin resistance.
Study design
0 and 4 weeks
Intervention
allogenic healthy (postbariatric surgery) donor feces transplantation + placebo tablets for 4 weeks VERSUS autologous fecal transplantation + sodium butyrate tablets for 4 weeks
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
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, HDL-cholesterol 1.04 mmol/l, blood pressure ≥ 130/85 mmHg
- Subjects should be able and willing to give informed consent
Exclusion criteria
-Any Medication use, including PPI and antibiotics in last 3 months
- Drug abuse
- Alcohol abuse (>3/day)
- Participation in a research protocol involving radiation exposure in the last 2 years.
- eGFR <60 ml/min
- Contraindication for MRI (claustrophobia)
- 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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4488 |
| NTR-old | NTR4713 |
| Other | : MEC 14/084 |