Endocrine System DiseasesPhase 1NCT02020395
Effect of a Test Meal on Satiation Hormones in Obese and Normal Weight Adolescents
A Phase 1 study testing test meal (500 kcal) in people with Endocrine System Diseases, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Endocrine System Diseases
- What is being tested?
- test meal (500 kcal)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2009to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- caucasian youth
- pubertal Tanner stage x, y, or z
Who cannot join
- fasting plasma glucose > 7.0 mmol/L
- significant illness
- taking medications
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Division of Gastroenterology and Hepatology
Basel, 4031
About this study
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.
Read the 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
- Being tested
- test meal (500 kcal)
- Medical subject headings
- Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)Dietary supplement
whole wheat bread (68 g), butter(10 g), ham (25 g); chocolate cream (90 g); orange juice (200 mL)
| Study group | Role | What they receive |
|---|---|---|
| Test meal (500 kcal)_normal weight | Placebo comparator | ham sandwich chocolate cream orange juice Receives: Dietary Supplement: test meal (500 kcal) |
| Test meal (500 kcal)_obese weight | Active comparator | ham sandwich chocolate cream orange juice Receives: Dietary Supplement: test meal (500 kcal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours blood sampling
Secondary outcomes (1)
Association between gastrointestinal peptides and insulin release
Dynamics of gastrointestinal peptide secretion including Tmax and Cmax
Measured: 2 hours blood sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine System DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital Basel
- Responsible party
- Sponsor
- Investigators
- Christoph Beglinger, MD, Principal investigator, Division of Gastroenterology and Hepatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020395
- Sponsor's protocol ID
- GI peptides obese adolescents
- Status last verified
- Dec 2013
- First submitted
- 12 Dec 2013
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Test Meal on Satiation Hormones in Obese and Normal Weight Adolescents
- ClinicalTrials.gov ID
- NCT02020395
- Acronym / sponsor ID
- GI peptides obese adolescents
- Conditions
- Endocrine System Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University Children's Hospital Basel
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test meal (500 kcal)_normal weight | Placebo comparator | Dietary Supplement: test meal (500 kcal)ham sandwich chocolate cream orange juice |
| Test meal (500 kcal)_obese weight | Active comparator | Dietary Supplement: test meal (500 kcal)ham sandwich chocolate cream orange juice |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- caucasian youth
- pubertal Tanner stage x, y, or z
Key exclusion criteria (3 listed)
- fasting plasma glucose > 7.0 mmol/L
- significant illness
- taking medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| test meal (500 kcal)whole wheat bread (68 g), butter(10 g), ham (25 g); chocolate cream (90 g); orange juice (200 mL) | Dietary supplement | Test meal (500 kcal)_normal weight |
| test meal (500 kcal)whole wheat bread (68 g), butter(10 g), ham (25 g); chocolate cream (90 g); orange juice (200 mL) | Dietary supplement | Test meal (500 kcal)_obese weight |
Primary outcome
Comparison of gastrointestinal peptide secretion in normal weight and obese adolescents
Time frame: 2 hours blood sampling
Relation of GLP-1 release to insulin secretion in normal weight and obese adolescents
1 secondary outcome
Association between gastrointestinal peptides and insulin release
Time frame: 2 hours blood sampling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Beglinger, MD principal investigator
Division of Gastroenterology and Hepatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing test meal (500 kcal) in people with Endocrine System Diseases, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of gastrointestinal peptide secretion in normal weight and obese adolescents (time frame: 2 hours blood sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2013.