Bariatric Surgery (Gastric Bypass), Severe Obesity
Conditions
Brief summary
After gastric bypass, 10-20% of patients will obtain a suboptimal weight loss, often defined as \<50% of the excess body weight. Exaggerated meal related secretion of gut hormones seem important for appetite reduction and subsequent weight loss after gastric bypass, however it is not clear whether different gut hormone responses are responsible for different postoperative weight loss responses. The purpose of the study is to investigate gut hormone secretion, vagal integrity and the effect of octreotide on ad libitum food intake in patients with suboptimal weight loss after gastric bypass and compare results to a matched group of gastric bypass operated patients with high postoperative weight loss but similar age, sex and preoperative BMI.
Interventions
OTHERMeal tests after saline injection
Fixed breakfast meal and ad libitum lunch meal
OTHERMeal tests after octreotide injection
Fixed breakfast meal and ad libitum lunch meal
OTHERSham feeding
Sponsors
University of Copenhagen
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Uncomplicated primary Roux-en-Y gastric bypass \>12 months ago * Postoperative weight loss of \>60%EBL or \<50%EBL.
Exclusion criteria
* Inadequately treated thyroid disease * Hemoglobin \<6.5 mM * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucagon-like peptide-1 (GLP-1) secretion (Between groups difference in incremental Area-under-the curve (iAUC) GLP-1 after fixed breakfast meal on saline day) | 0-240 min | Between groups difference in iAUC GLP-1 after fixed breakfast meal on saline day |
| Ghrelin secretion (Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day) | 0-240 min | Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day |
| Peptide YY (PYY) secretion (Between groups difference in iAUC PYY after fixed breakfast meal on saline day) | 0-240 min | Between groups difference in iAUC PYY after fixed breakfast meal on saline day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ad libitum food intake | 240 min | Between groups difference in ad lib food intake |
| Effect of octreotide on Ad libitum food intake (Between groups difference in %change in ad lib food intake between saline and octreotide day) | 240 min | Between groups difference in %change in ad lib food intake between saline and octreotide day |
| Vagal insufficiency (Between groups difference in % change in pancreatic polypeptide (PP) from fasting to early peak levels (15-30 min) after sham feeding) | 0-30 min | Between groups difference in % change in PP from fasting to early peak levels (15-30 min) after sham feeding |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota (Between groups differences in gut microbiome investigated with next generation sequencing) | feces sample at home before intervention | Between groups differences in gut microbiome investigated with next generation sequencing |
| Genetic profile (Between groups differences in gene variants investigated with a HumanCoreExome chip) | 0 min | Between groups differences in gene variants investigated with a HumanCoreExome chip |
| Food intake (Between groups differences in food intake evaluated by questionnaires and diet registration) | 4 weeks questionnaires and 4 days of registration | Between groups differences in food intake evaluated by questionnaires and diet registration |
| Physical activity (Between groups differences in food intake evaluated by questionnaires and accelerometer) | 4 weeks questionnaires and14 days of registration | Between groups differences in food intake evaluated by questionnaires and accelerometer |
| Appetite scores (Between groups differences in VAS scores after meal test and sham feeding test) | 0-240 min, 240-270 min, 0-75 min | Between groups differences in VAS scores after meal test and sham feeding test |
Countries
Denmark
Outcome results
None listed