Clinical trial NCT02374632: Gut Hormones as Mediators of Different Weight Loss Responses After Roux-en-Y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bariatric Surgery (Gastric Bypass)
Severe Obesity
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2015-03-02
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 0-240 min
measure: Peptide YY (PYY) secretion (Between groups difference in iAUC PYY after fixed breakfast meal on saline day)
timeFrame: 0-240 min
measure: Ghrelin secretion (Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day)
timeFrame: 0-240 min
Secondary outcomes:
measure: Ad libitum food intake
timeFrame: 240 min
measure: Effect of octreotide on Ad libitum food intake (Between groups difference in %change in ad lib food intake between saline and octreotide day)
timeFrame: 240 min
measure: Vagal insufficiency (Between groups difference in % change in pancreatic polypeptide (PP) from fasting to early peak levels (15-30 min) after sham feeding)
timeFrame: 0-30 min
Other outcomes:
measure: Appetite scores (Between groups differences in VAS scores after meal test and sham feeding test)
timeFrame: 0-240 min, 240-270 min, 0-75 min
measure: Genetic profile (Between groups differences in gene variants investigated with a HumanCoreExome chip)
timeFrame: 0 min
measure: Gut microbiota (Between groups differences in gut microbiome investigated with next generation sequencing)
timeFrame: feces sample at home before intervention
measure: Food intake (Between groups differences in food intake evaluated by questionnaires and diet registration)
timeFrame: 4 weeks questionnaires and 4 days of registration
measure: Physical activity (Between groups differences in food intake evaluated by questionnaires and accelerometer)
timeFrame: 4 weeks questionnaires and14 days of registration
Locations:
city: Hvidovre
country: Denmark
facility: Department of Endocrinology, Hvidovre Hospital
Study officials:
References: