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

Severe Obesity Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02374632
• Other study ID #: KBM-R2-14
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 17, 2015
• Last updated: February 6, 2017
• Start date: October 2014
• Est. completion date: June 2017

Study information

• Verified date: February 2017
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery (Gastric Bypass)
• Obesity, Morbid
• Severe Obesity

Intervention

Other:
• Meal tests after saline injection
Fixed breakfast meal and ad libitum lunch meal
• Meal tests after octreotide injection
Fixed breakfast meal and ad libitum lunch meal
• Sham feeding

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Hvidovre Hospital	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Genetic profile (Between groups differences in gene variants investigated with a HumanCoreExome chip)	Between groups differences in gene variants investigated with a HumanCoreExome chip	0 min
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Secondary	Ad libitum food intake	Between groups difference in ad lib food intake	240 min
Secondary	Effect of octreotide on Ad libitum food intake (Between groups difference in %change in ad lib food intake between saline and octreotide day)	Between groups difference in %change in ad lib food intake between saline and octreotide day	240 min
Secondary	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