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

Primary Purpose

Endocrine System Diseases

Status

Completed

Phase

Phase 1

Locations

Switzerland

Study Type

Interventional

Intervention

test meal (500 kcal)

About this trial

This is an interventional basic science trial for Endocrine System Diseases

Eligibility Criteria

11 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

caucasian youth
pubertal Tanner stage x, y, or z

Exclusion Criteria:

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

Sites / Locations

University Hospital Basel, Division of Gastroenterology and Hepatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Test meal (500 kcal)_normal weight

Test meal (500 kcal)_obese weight

Arm Description

ham sandwich chocolate cream orange juice

Outcomes

Primary Outcome Measures

Comparison of gastrointestinal peptide secretion in normal weight and obese adolescents

Relation of GLP-1 release to insulin secretion in normal weight and obese adolescents

Secondary Outcome Measures

Association between gastrointestinal peptides and insulin release

Dynamics of gastrointestinal peptide secretion including Tmax and Cmax

Full Information

NCT ID

NCT02020395

First Posted

December 12, 2013

Last Updated

December 18, 2013

Sponsor

University Hospital, Basel, Switzerland

Collaborators

University Children's Hospital Basel

1. Study Identification

Unique Protocol Identification Number

NCT02020395

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

Collaborators

University Children's Hospital Basel

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endocrine System Diseases

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test meal (500 kcal)_normal weight

Arm Type

Placebo Comparator

Arm Description

ham sandwich chocolate cream orange juice

Arm Title

Test meal (500 kcal)_obese weight

Arm Type

Active Comparator

Arm Description

ham sandwich chocolate cream orange juice

Intervention Type

Dietary Supplement

Intervention Name(s)

test meal (500 kcal)

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

test meal (500 kcal)

Intervention Description

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

Primary Outcome Measure Information:

Title

Comparison of gastrointestinal peptide secretion in normal weight and obese adolescents

Description

Relation of GLP-1 release to insulin secretion in normal weight and obese adolescents

Time Frame

2 hours blood sampling

Secondary Outcome Measure Information:

Title

Association between gastrointestinal peptides and insulin release

Description

Dynamics of gastrointestinal peptide secretion including Tmax and Cmax

Time Frame

2 hours blood sampling

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph Beglinger, MD

Organizational Affiliation

Division of Gastroenterology and Hepatology, University Hospital Basel

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Basel, Division of Gastroenterology and Hepatology

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

12. IPD Sharing Statement

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

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