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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low EBL | Other | Gastric bypass operated patients with low postoperative excess body weight loss (EBL) <50%. Interventions: Meal tests after saline/octreotide injection in a randomized order, sham feeding. |
|
| High EBL | Other | Gastric bypass operated patients with high postoperative excess body weight loss (EBL) >70% matched with respect to age, gender and preoperative BMI in the LowEBL group. Interventions: Meal tests after saline/octreotide injection in a randomized order, sham feeding. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meal tests after saline injection | Other | Fixed breakfast meal and ad libitum lunch meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Between groups difference in iAUC GLP-1 after fixed breakfast meal on saline day | 0-240 min |
| Peptide YY (PYY) secretion (Between groups difference in iAUC PYY after fixed breakfast meal on saline day) | Between groups difference in iAUC PYY after fixed breakfast meal on saline day | 0-240 min |
| Ghrelin secretion (Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day) | Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day | 0-240 min |
| Measure | Description | Time Frame |
|---|---|---|
| Ad libitum food intake | Between groups difference in ad lib food intake | 240 min |
| Effect of octreotide on Ad libitum food intake (Between groups difference in %change in ad lib food intake between saline and octreotide day) |
| Measure | Description | Time Frame |
|---|---|---|
| Appetite scores (Between groups differences in VAS scores after meal test and sham feeding test) | Between groups differences in VAS scores after meal test and sham feeding test | 0-240 min, 240-270 min, 0-75 min |
| Genetic profile (Between groups differences in gene variants investigated with a HumanCoreExome chip) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, Hvidovre Hospital | Hvidovre | DK-2650 | Denmark |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Meal tests after octreotide injection | Other | Fixed breakfast meal and ad libitum lunch meal |
|
| Sham feeding | Other |
|
Between groups difference in %change in ad lib food intake between saline and octreotide day
| 240 min |
| Vagal insufficiency (Between groups difference in % change in pancreatic polypeptide (PP) from fasting to early peak levels (15-30 min) after sham feeding) | Between groups difference in % change in PP from fasting to early peak levels (15-30 min) after sham feeding | 0-30 min |
Between groups differences in gene variants investigated with a HumanCoreExome chip |
| 0 min |
| Gut microbiota (Between groups differences in gut microbiome investigated with next generation sequencing) | Between groups differences in gut microbiome investigated with next generation sequencing | feces sample at home before intervention |
| Food intake (Between groups differences in food intake evaluated by questionnaires and diet registration) | Between groups differences in food intake evaluated by questionnaires and diet registration | 4 weeks questionnaires and 4 days of registration |
| Physical activity (Between groups differences in food intake evaluated by questionnaires and accelerometer) | Between groups differences in food intake evaluated by questionnaires and accelerometer | 4 weeks questionnaires and14 days of registration |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |