The aim of this study is to assess the effects of a sleeve gastrectomy and a Roux-en-Y gastric bypass on satiety, gastrointestinal transit and hormone release.
ID
Source
Brief title
Condition
- Other condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Gastrointestinal therapeutic procedures
Synonym
Health condition
morbide obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the effect of a sleeve gastrectomy and gastric bypass on satiety,
diabetes and hormone release.
To assess the effect of a sleeve gastrectomy and gastric bypass on gastric
emptying and intestinal transit time.
Secondary outcome
To assess correlation between hormone release and transit time in both
procedures
Background summary
Obesity is an increasing problem in the Western world. Obese subjects show
reduced satiety after food intake compared to lean subjects. Today, bariatric
surgery
seems to be the only effective treatment with long term results.
Bariatric surgery induces a change in satiety hormones. After Roux-en-Y gastric
bypass GLP-1 and PYY directly increase before weight loss has occurred.
Although ghrelin levels may vary in different studies. Sleeve gastrectomy does
not bypass the duodenum and yet has shown to have induced massive weight loss.
Changes in ghrelin and PYY have been observed only. No studies have
investigated the release of GLP-1 and CCK.
Gastric emptying is accelerated after sleeve gastrectomy and Roux-en-Y gastric
bypass. It is not known how this is related to the change in hormones.
Intestinal transit has not been investigated after sleeve gastrectomy and only
in few studies after Roux-en-Y gastric bypass.
Study objective
The aim of this study is to assess the effects of a sleeve gastrectomy and a
Roux-en-Y gastric bypass on satiety, gastrointestinal transit and hormone
release.
Study design
On three test days, the patient will receive a meal consisting of two slices of
white bread and an egg, the yolk of which was doped with 100 mg 13 C octanoid
acid, sodium salt in order to measure gastric emptying. To this meal 10 g of
lactulose will be added, to enable measurements of small bowel transit time .
The first test day will be before the SG or RYGB, the second test day will be
4-6 weeks after surgery, the third test day will be after one year. During
admission an oral glucose tolerance test will be performed twice (one before
surgery and one on the third day after surgery). This outline was chosen to
assess the direct effects and long term effects on satiety, glucose
homeostasis, hormone release and transit time.
Study burden and risks
• fasting from 24:00 in the evening until 8:30 the next morning (before the
testday)
• venous blood sampling procedure (via intravenous cannula)
Benefit for patients individually are none.
Benefit for obesity research in general is providing a better insight in
obesity and satiety hormones before and after weight loss/surgery possible
leading to the development of less invasive treatments and antiobesity drugs.
Benefit for obese patients in genera may be a better preselection of patients
who may benefit most of either sleeve gastrectomy or RYGB preventing secundairy
surgery due to failure.
Meidoorn 116
6226 WD Maastricht
NL
Meidoorn 116
6226 WD Maastricht
NL
Listed location countries
Age
Inclusion criteria
Morbidly obese BMI > 35 - 50 (35-40 + comorbidity) who are candidates for bariatric surgery (sleeve gastrectomy or RYGB)
Exclusion criteria
History of gastrointestinal surgery (other than cholecystectomy or appendectomy), gastrointestinal diseases that either affect transit or satiety.
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 |
|---|---|
| CCMO | NL27906.060.09 |