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

February 6, 2017 updated by: Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, DK-2650
        • Department of Endocrinology, Hvidovre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Low EBL

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)
Time Frame: 0-240 min
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)
Time Frame: 0-240 min
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)
Time Frame: 0-240 min
Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day
0-240 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ad libitum food intake
Time Frame: 240 min
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)
Time Frame: 240 min
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)
Time Frame: 0-30 min
Between groups difference in % change in PP from fasting to early peak levels (15-30 min) after sham feeding
0-30 min

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite scores (Between groups differences in VAS scores after meal test and sham feeding test)
Time Frame: 0-240 min, 240-270 min, 0-75 min
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)
Time Frame: 0 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)
Time Frame: feces sample at home before intervention
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)
Time Frame: 4 weeks questionnaires and 4 days of 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)
Time Frame: 4 weeks questionnaires and14 days of registration
Between groups differences in food intake evaluated by questionnaires and accelerometer
4 weeks questionnaires and14 days of registration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Collaborators

University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

March 2, 2015

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBM-R2-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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