Gut Hormones as Mediators of Different Weight Loss Responses After Roux-en-Y Gastric Bypass

Phase 4

• Conditions: Severe Obesity; Bariatric Surgery (Gastric Bypass)
• Interventions: Other: Meal tests after saline injection; Other: Meal tests after octreotide injection; Other: Sham feeding

• Registration Number: NCT02374632
• Lead Sponsor: Hvidovre University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-02
• Primary Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-07
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low EBL	Meal tests after octreotide injection	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.
Low EBL	Meal tests after saline injection	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.
Low EBL	Sham feeding	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	Sham feeding	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.
High EBL	Meal tests after saline injection	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.
High EBL	Meal tests after octreotide injection	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.

Primary Outcome Measures

Name	Time	Method
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
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
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

Secondary Outcome Measures

Name	Time	Method
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
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
Ad libitum food intake	240 min	Between groups difference in ad lib food intake

Trial Locations

Locations (1)

Department of Endocrinology, Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark