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

NCT ID: NCT02020395

Last Updated: 2013-12-24

Basic Information

• 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

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.

Conditions

Endocrine System Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

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

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

University Children's Hospital Basel

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Beglinger, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Gastroenterology and Hepatology, University Hospital Basel

Locations

University Hospital Basel, Division of Gastroenterology and Hepatology

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

GI peptides obese adolescents

Identifier Type: -

Identifier Source: org_study_id