To assess gastric emptying rates and incretin levels in good and bad responders two years after LRYGB and LSG. Additionally, gastric emptying rate is assessed before and after placement of the DJBL in overweight patients with T2DM.
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gastric emptying rate and incretin levels two years after LRYGB and LSG, and
gastric emptying before and 1 month after DJBL implantation.
Secondary outcome
- Weight loss/ excess weight loss two years after Roux-en-Y Gastric Bypass and
Sleeve Gastrectomy
- Quality of life two years after Roux-en-Y Gastric Bypass and Sleeve
Gastrectomy
- Quality of life before and one month after implantation of the
duodenal-jejunal bypass liner
Background summary
The two most performed types of bariatric surgery in the Netherlands are the
Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) and the Laparoscopic Sleeve
Gastrectomy (LSG). Additionally, less invasive methods to control overweight
and type 2 Diabetes Mellitus (T2DM) are available, such as the duodenal-jejunal
bypass liner (DJBL).
The mechanism of bariatric procedures is still not fully understood. Stomach
volume is decreased and satiety levels often increase, probably due to changes
in incretin levels. Passage of foods through the gastrointestinal tract are
altered.
Patients response on the different bariatric procedure varies widely and it is
difficult to predict which patient responds well. It is unclear if patients who
have successful excess weight loss (EWL) two years after surgery have different
Gastric emptying (GE) rates than unsuccessful patients. Additionally, it is
unclear if incretin levels differ between successful and unsuccessful patients.
Gastric emptying after placement of a DJBL is unclear. However, changes in
incretin levels before and after DJBL implantation are already demonstrated in
earlier studies.
We hypothesize that GE of solid food is increased in good responders in terms
of weight loss compared to bad responders after LRYGB and LSG. Additionally we
hypothesize that different incretin levels are observed in good and bad
responders. Regarding the DJBL we hypothesize that GE will decrease after
implantation compared to GE prior to implantation.
Study objective
To assess gastric emptying rates and incretin levels in good and bad responders
two years after LRYGB and LSG. Additionally, gastric emptying rate is assessed
before and after placement of the DJBL in overweight patients with T2DM.
Study design
A prospective trial in which gastric emptying rate and incretin levels are
measured in good and bad responders two years after LRYGB and LSG. Gastric
emptying rate is assessed before and after placement of the DJBL in overweight
patients with T2DM.
Study burden and risks
Patients will undergo a gastric emptying study two years after bariatric
surgery, or before and one month after implantation of the DJBL.. The nucleair
radiation burden is 0.5 mSv for LRYGB and LSG patients, and 1.0 mSv (2 times
0.5 mSv) for patients receiving the DJBL.. For LRYGB and LSG patients this
burden is comparable with a transatlantic flight (0.4 mSv) and for patients
receiving the DJBL this is half of the annual national background radiation in
the Netherlands (2 mSv/ year).
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
Inclusion criteria
I.
Patients who are approaching their two years follow-up after Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) and Laparoscopic Sleeve Gastrectomy (LSG) are eligble for inclusion. The patients will be arranged in one of the following four groups according to the Reinhold*s criteria:;- Good responders (EWL > 50%) two years after RYGB
- Bad responders (EWL < 25%) two years after RYGB
- Good responders (EWL > 50%) two years after LSG
- Bad responders (EWL < 25%) two years after LSG;II.
Patients who are eligble for duodenal-jejunal bypass liner implantation. These patients have been diagnosed with type 2 and a BMI 28-45 kg/m2.
Exclusion criteria
- Binge-eating or associated eating disorder
- Active drug or alcohol addiction
- Gluten allergy
- Inability to stop medication that affects the motility of the upper gastrointestinal tract (anti-cholinergic drugs, prokinetics, theophylline, calcium blocking agents, opioids)
- Endocrine disease influencing gastric emptying (diabetes mellitus, hyper- or hypothyroidism). T2DM is not an exclusion criteria for patients receiving the DJBL because T2DM is a requirement for receiving the DJBL. Additionally, changes in GE rate will be determined 1 month after implantation. No significant changes in GE rate will be expected in this time period caused by their T2DM
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 | NL50111.091.14 |