NCT02374632

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

February 17, 2015

Last Update Submit

February 6, 2017

Conditions

Bariatric Surgery (Gastric Bypass)Severe Obesity

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (3)

  • Ad libitum 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)

    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)

    0-30 min

Other Outcomes (5)

  • Appetite scores (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)

    0 min

  • Gut microbiota (Between groups differences in gut microbiome investigated with next generation sequencing)

    feces sample at home before intervention

  • +2 more other outcomes

Study Arms (2)

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.

Other: Meal tests after saline injectionOther: Meal tests after octreotide injectionOther: 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.

Other: Meal tests after saline injectionOther: Meal tests after octreotide injectionOther: Sham feeding

Interventions

Meal tests after saline injectionOTHER

Fixed breakfast meal and ad libitum lunch meal

High EBLLow EBL
Meal tests after octreotide injectionOTHER

Fixed breakfast meal and ad libitum lunch meal

High EBLLow EBL
Sham feedingOTHER
High EBLLow EBL

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Uncomplicated primary Roux-en-Y gastric bypass \>12 months ago
  • Postoperative weight loss of \>60%EBL or \<50%EBL.

You may not qualify if:

  • Inadequately treated thyroid disease
  • Hemoglobin \<6.5 mM
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Hvidovre Hospital

Hvidovre, DK-2650, Denmark

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 17, 2015

First Posted

March 2, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

DK(1)