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…
ID
Bron
Verkorte titel
Aandoening
insulin resistance, overweight, gutmicrobiota
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Insulin sensitivity and lipolysis (2-step hyperinsulinemic euglycemic clamp)<br>
- Hypothalamic (SPECT-scan), small intestinal (biopsy) and urinal (24h urine sample) serotonin levels in relation to satiety testing
Achtergrond van het onderzoek
In this RCT we aim to dissect whether intestinal microbiota or their product butyrate affect human (serotonin) driven satiety and insulin resistance in humans.
Doel van het onderzoek
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.
Onderzoeksopzet
0 and 4 weeks
Onderzoeksproduct en/of interventie
allogenic healthy (postbariatric surgery) donor feces transplantation + placebo tablets for 4 weeks VERSUS autologous fecal transplantation + sodium butyrate tablets for 4 weeks
Publiek
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
Wetenschappelijk
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-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)
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4488 |
| NTR-old | NTR4713 |
| Ander register | : MEC 14/084 |