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

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.

Study Overview

• Status: Completed
• Conditions: Endocrine System Diseases
• Intervention / Treatment: Dietary supplement: test meal (500 kcal)

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel, Division of Gastroenterology and Hepatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 hours blood sampling

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between gastrointestinal peptides and insulin release	Dynamics of gastrointestinal peptide secretion including Tmax and Cmax	2 hours blood sampling

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: University Children's Hospital Basel
• Investigators: Principal Investigator: Christoph Beglinger, MD, Division of Gastroenterology and Hepatology, University Hospital Basel

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: December 12, 2013
• First Submitted That Met QC Criteria: December 18, 2013
• First Posted (Estimate): December 24, 2013

Study Record Updates

• Last Update Posted (Estimate): December 24, 2013
• Last Update Submitted That Met QC Criteria: December 18, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases
• Other Study ID Numbers: GI peptides obese adolescents