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Effect of a Test Meal on Satiation Hormones in Obese and Normal Weight Adolescents

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ClinicalTrials.gov Identifier: NCT02020395
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : December 24, 2013
Sponsor:
Collaborator:
University Children's Hospital Basel
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
The objective of this study is to examine ghrelin, amylin, glucagon and glucagon-like peptide (GLP)-1 responses to a test meal in lean and obese individuals.

Condition or disease Intervention/treatment Phase
Endocrine System Diseases Dietary Supplement: test meal (500 kcal) Phase 1

Detailed Description:
The primary hypothesis is that obese adolescents have a disturbed balance of hormones associated with appetite regulation with less suppression of ghrelin and attenuated stimulation of GLP-1 secretion in response to meal intake compared to lean normal weight controls. A second aim of the study was to test which gastrointestinal peptides are most associated with insulin resistance.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of a Test Meal on Satiation Hormones in Obese and Normal Weight Adolescents
Study Start Date : June 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Test meal (500 kcal)_normal weight
ham sandwich chocolate cream orange juice
Dietary Supplement: test meal (500 kcal)
whole wheat bread (68 g), butter(10 g), ham (25 g); chocolate cream (90 g); orange juice (200 mL)

Active Comparator: Test meal (500 kcal)_obese weight
ham sandwich chocolate cream orange juice
Dietary Supplement: test meal (500 kcal)
whole wheat bread (68 g), butter(10 g), ham (25 g); chocolate cream (90 g); orange juice (200 mL)




Primary Outcome Measures :
  1. Comparison of gastrointestinal peptide secretion in normal weight and obese adolescents [ Time Frame: 2 hours blood sampling ]
    Relation of GLP-1 release to insulin secretion in normal weight and obese adolescents


Secondary Outcome Measures :
  1. Association between gastrointestinal peptides and insulin release [ Time Frame: 2 hours blood sampling ]
    Dynamics of gastrointestinal peptide secretion including Tmax and Cmax



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Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • caucasian youth
  • pubertal Tanner stage x, y, or z

Exclusion Criteria:

  • fasting plasma glucose > 7.0 mmol/L
  • significant illness
  • taking medications

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): NCT02020395


Locations
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Switzerland
University Hospital Basel, Division of Gastroenterology and Hepatology
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University Children's Hospital Basel
Investigators
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Principal Investigator: Christoph Beglinger, MD Division of Gastroenterology and Hepatology, University Hospital Basel
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02020395    
Other Study ID Numbers: GI peptides obese adolescents
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Endocrine System Diseases