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Trial · Interventional

Status unknownPhase 4Registry data

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

NCTNCT02374632 (opens ClinicalTrials.gov in a new tab)Other idKBM-R2-14
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Overview

Status
Status unknown
Phase
Phase 4
Enrollment
40 participants (actual)
Sponsor
Hvidovre University Hospital · Other
Design
Randomized · Single masking
Countries
1 country

Denmark

Start
Oct 2014
Primary completion
Dec 2016
Completion
Jun 2017 (estimated)
First posted
2 Mar 2015 (estimated)
Last update posted
7 Feb 2017 (estimated)
Conditions
Bariatric Surgery (Gastric Bypass) · Severe Obesity

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015201620172018
  1. Ph 4

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

    NCT02374632

    Oct 2014 to est. Jun 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Meal tests after saline injectionOther
  • Meal tests after octreotide injectionOther
  • Sham feedingOther

Arms2

  • 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

    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.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    Between groups difference in iAUC GLP-1 after fixed breakfast meal on saline day

  2. Peptide YY (PYY) secretion (Between groups difference in iAUC PYY after fixed breakfast meal on saline day)

    Time frame · 0-240 min

    Registry description

    Between groups difference in iAUC PYY after fixed breakfast meal on saline day

  3. Ghrelin secretion (Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day)

    Time frame · 0-240 min

    Registry description

    Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day

Secondary outcomes(3)

  1. Ad libitum food intake

    Time frame · 240 min

    Registry description

    Between groups difference in ad lib food intake

  2. 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

    Registry description

    Between groups difference in %change in ad lib food intake between saline and octreotide day

  3. 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

    Registry description

    Between groups difference in % change in PP from fasting to early peak levels (15-30 min) after sham feeding

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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