No registrations found.
ID
Source
Brief title
Health condition
insulin resistance
intestinal microbiota
fecal transplantation
Sponsors and support
Intervention
Outcome measures
Primary outcome
changes in insulin sensitivity (hyperinsulinemic euglycemic clamp with ([6,6-2H2]labeled glucose) [1,1,2,3,3-2H5]labeled glycerol) and fecal energy excretion (caloric bomb) between baseline and 2 weeks after treatment.
Secondary outcome
Changes in adipose tissue inflammation in subcutaneous adipose tissue (biopsy) for insulin signalling cascade in relation to metabolic genes and macrophage counts; Intestinal transit time; fecal bileacids and shortchain fatty acids; Gut microbiota composition in small duodenal biopsies and feces
Background summary
this study aims to dissect causality of intestinal microbiota in metabolic improvements (insulin resistance) seen in postbariatric surgery subjects using fecal transplantation.
Study objective
To investigate the effect of gutmicrobiota infusion harvested from pre- vs post-RYGB donors on microbiome-induced, lipid-mediated insulin resistance in insulin resistant subjects.
Study design
metabolic syndrome subjects: baseline and 2 weeks after fecal transplantation.
donors: baseline
Intervention
fecal transplantation using either feces from subjects after bariatric surgery or subjects before bariatric surgery in metablic syndrome
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
Male obese treatment naieve subjects with metabolic syndrome (n=22, 21 to 65 years-old; with metabolic syndrome
Able to give informed consent.
Exclusion criteria
history of cardiovascular event (MI or pacemaker implantation)
cholecystectomy,
use of medication including PPI and antibiotics past three months,
(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 | NL4168 |
| NTR-old | NTR4327 |
| Other | : MEC 2013/090 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |