Effect of the BaroSense ACE Stapler procedure on food intake, food-reward, gastric emptying, hormone release, inflammatory profile, gut microbiota and behaviour towards food.

Effect of the BaroSense ACE Stapler procedure on food intake, food-reward, gastric emptying, hormone release, inflammatory profile, gut microbiota and behaviour towards food. - BaroSense ACE Stapler Sub-study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37637

Enrollment

Registered

2012-06-27

Start date

2012-07-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

extreme overweight obesity

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient is included in the main BaroSense ACE Stapler study.

Exclusion criteria

Exclusion criteria: presence of contra-indications for MRI claustrophobia pregnancy

Design outcomes

Primary

Measure	Time frame
To assess the effect of the BaroSense ACE Stapler on satiety, satiation, food intake and hunger.	—

Secondary

Measure	Time frame
• To investigate the effect of stomach tissue ligation by the ACE Stapler on gastro-intestinal hormone release (CCK, GLP-1, PYY, Ghrelin and Leptin) • To asses the effect of stomach tissue ligation by the ACE Stapler on gastric volume and gastric emptying rate (by real time MRI and 13C octanoic acid breath test) • To asses the effect of stomach tissue ligation by the ACE Stapler on ad libitum meal intake and post-prandial satiety • To investigate the effect of stomach tissue ligation by the ACE Stapler on several inflammatory markers • To compare the gastric emptying time of the MRI with the 13C octanoic acid breath test • To investigate the effect of stomach tissue ligation by the ACE Stapler on food-reward • To investigate the effect of stomach tissue ligation by the ACE Stapler behaviour towards food • To investigate the effect on expression and localisation of nutrient receptors in the stomach and duodenum	—

Measure

Time frame

• To investigate the effect of stomach tissue ligation by the ACE Stapler on gastro-intestinal hormone release (CCK, GLP-1, PYY, Ghrelin and Leptin) • To asses the effect of stomach tissue ligation by the ACE Stapler on gastric volume and gastric emptying rate (by real time MRI and 13C octanoic acid breath test) • To asses the effect of stomach tissue ligation by the ACE Stapler on ad libitum meal intake and post-prandial satiety • To investigate the effect of stomach tissue ligation by the ACE Stapler on several inflammatory markers • To compare the gastric emptying time of the MRI with the 13C octanoic acid breath test • To investigate the effect of stomach tissue ligation by the ACE Stapler on food-reward • To investigate the effect of stomach tissue ligation by the ACE Stapler behaviour towards food • To investigate the effect on expression and localisation of nutrient receptors in the stomach and duodenum

—

Countries

Netherlands

Outcome results