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

Primary Purpose

Bariatric Surgery (Gastric Bypass), Severe Obesity

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Meal tests after saline injection
Meal tests after octreotide injection
Sham feeding
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bariatric Surgery (Gastric Bypass)

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Endocrinology, Hvidovre Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Low EBL

High EBL

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Ad libitum food intake
Between groups difference in ad lib food intake
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
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

Full Information

First Posted
February 17, 2015
Last Updated
February 6, 2017
Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02374632
Brief Title
Gut Hormones as Mediators of Different Weight Loss Responses After Roux-en-Y Gastric Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery (Gastric Bypass), Severe Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low EBL
Arm Type
Other
Arm Description
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.
Arm Title
High EBL
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Meal tests after saline injection
Intervention Description
Fixed breakfast meal and ad libitum lunch meal
Intervention Type
Other
Intervention Name(s)
Meal tests after octreotide injection
Intervention Description
Fixed breakfast meal and ad libitum lunch meal
Intervention Type
Other
Intervention Name(s)
Sham feeding
Primary Outcome Measure Information:
Title
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)
Description
Between groups difference in iAUC GLP-1 after fixed breakfast meal on saline day
Time Frame
0-240 min
Title
Peptide YY (PYY) secretion (Between groups difference in iAUC PYY after fixed breakfast meal on saline day)
Description
Between groups difference in iAUC PYY after fixed breakfast meal on saline day
Time Frame
0-240 min
Title
Ghrelin secretion (Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day)
Description
Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day
Time Frame
0-240 min
Secondary Outcome Measure Information:
Title
Ad libitum food intake
Description
Between groups difference in ad lib food intake
Time Frame
240 min
Title
Effect of octreotide on Ad libitum food intake (Between groups difference in %change in ad lib food intake between saline and octreotide day)
Description
Between groups difference in %change in ad lib food intake between saline and octreotide day
Time Frame
240 min
Title
Vagal insufficiency (Between groups difference in % change in pancreatic polypeptide (PP) from fasting to early peak levels (15-30 min) after sham feeding)
Description
Between groups difference in % change in PP from fasting to early peak levels (15-30 min) after sham feeding
Time Frame
0-30 min
Other Pre-specified Outcome Measures:
Title
Appetite scores (Between groups differences in VAS scores after meal test and sham feeding test)
Description
Between groups differences in VAS scores after meal test and sham feeding test
Time Frame
0-240 min, 240-270 min, 0-75 min
Title
Genetic profile (Between groups differences in gene variants investigated with a HumanCoreExome chip)
Description
Between groups differences in gene variants investigated with a HumanCoreExome chip
Time Frame
0 min
Title
Gut microbiota (Between groups differences in gut microbiome investigated with next generation sequencing)
Description
Between groups differences in gut microbiome investigated with next generation sequencing
Time Frame
feces sample at home before intervention
Title
Food intake (Between groups differences in food intake evaluated by questionnaires and diet registration)
Description
Between groups differences in food intake evaluated by questionnaires and diet registration
Time Frame
4 weeks questionnaires and 4 days of registration
Title
Physical activity (Between groups differences in food intake evaluated by questionnaires and accelerometer)
Description
Between groups differences in food intake evaluated by questionnaires and accelerometer
Time Frame
4 weeks questionnaires and14 days of registration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Endocrinology, Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark

12. IPD Sharing Statement

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

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