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

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ClinicalTrials.gov Identifier: NCT02374632
Recruitment Status : Unknown
Verified February 2017 by Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 2, 2015
Last Update Posted : February 7, 2017
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital

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.

Condition or disease Intervention/treatment Phase
Bariatric Surgery (Gastric Bypass) Severe Obesity Other: Meal tests after saline injection Other: Meal tests after octreotide injection Other: Sham feeding Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Study Start Date : October 2014
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control
Drug Information available for: Octreotide

Arm Intervention/treatment
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
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



Primary Outcome Measures :
  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 ]
    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 ]
    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 ]
    Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day


Secondary Outcome Measures :
  1. Ad libitum food intake [ Time Frame: 240 min ]
    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 ]
    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 ]
    Between groups difference in % change in PP from fasting to early peak levels (15-30 min) after sham feeding


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374632


Locations
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Denmark
Department of Endocrinology, Hvidovre Hospital
Hvidovre, Denmark, DK-2650
Sponsors and Collaborators
Hvidovre University Hospital
University of Copenhagen

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Responsible Party: Kirstine Nyvold Bojsen-Moeller, MD, PhD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02374632     History of Changes
Other Study ID Numbers: KBM-R2-14
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents