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

NCT ID: NCT02020395

Last Updated: 2013-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Endocrine System Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Test meal (500 kcal)_normal weight

ham sandwich chocolate cream orange juice

Group Type PLACEBO_COMPARATOR

test meal (500 kcal)

Intervention Type DIETARY_SUPPLEMENT

whole wheat bread (68 g), butter(10 g), ham (25 g); chocolate cream (90 g); orange juice (200 mL)

Test meal (500 kcal)_obese weight

ham sandwich chocolate cream orange juice

Group Type ACTIVE_COMPARATOR

test meal (500 kcal)

Intervention Type DIETARY_SUPPLEMENT

whole wheat bread (68 g), butter(10 g), ham (25 g); chocolate cream (90 g); orange juice (200 mL)

Interventions

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test meal (500 kcal)

whole wheat bread (68 g), butter(10 g), ham (25 g); chocolate cream (90 g); orange juice (200 mL)

Intervention Type 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)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* fasting plasma glucose \> 7.0 mmol/L
* significant illness
* taking medications
Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Children's Hospital Basel

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph Beglinger, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Gastroenterology and Hepatology, University Hospital Basel

Locations

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University Hospital Basel, Division of Gastroenterology and Hepatology

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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GI peptides obese adolescents

Identifier Type: -

Identifier Source: org_study_id