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

Endocrine System Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020395
• Other study ID #: GI peptides obese adolescents
• Status: Completed
• Phase: Phase 1
• First received: December 12, 2013
• Last updated: December 18, 2013
• Start date: June 2009
• Est. completion date: October 2013

Study information

• Verified date: December 2013
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2013
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 16 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Endocrine System Diseases

Intervention

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)
• test meal (500 kcal)
whole wheat bread (68 g), butter(10 g), ham (25 g); chocolate cream (90 g); orange juice (200 mL)

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Division of Gastroenterology and Hepatology	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	University Children's Hospital Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Association between gastrointestinal peptides and insulin release	Dynamics of gastrointestinal peptide secretion including Tmax and Cmax	2 hours blood sampling	No