NCT02020395

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
Last Updated

December 24, 2013

Status Verified

December 1, 2013

Enrollment Period

6 months

First QC Date

December 12, 2013

Last Update Submit

December 18, 2013

Conditions

Endocrine System Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Association between gastrointestinal peptides and insulin release

    2 hours blood sampling

Study Arms (2)

Test meal (500 kcal)_normal weight

PLACEBO COMPARATOR

ham sandwich chocolate cream orange juice

Dietary Supplement: test meal (500 kcal)

Test meal (500 kcal)_obese weight

ACTIVE COMPARATOR

ham sandwich chocolate cream orange juice

Dietary Supplement: test meal (500 kcal)

Interventions

test meal (500 kcal)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)_normal weight

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Division of Gastroenterology and Hepatology

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Endocrine System Diseases

Study Officials

  • Christoph Beglinger, MD

    Division of Gastroenterology and Hepatology, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2013

First Posted

December 24, 2013

Study Start

June 1, 2009

Primary Completion

December 1, 2009

Study Completion

October 1, 2013

Last Updated

December 24, 2013

Record last verified: 2013-12

Locations

CH(1)