Healthy VolunteersNCT00869453
Gut Hormone Secretion and Macronutrients
An observational study of Healthy Volunteers, run by University of Lausanne at 2 sites in Switzerland.
Trial summary
The role of gut hormone (GLP-1, GIP, PYY...) in glucose homeostasis has been widely demonstrated. Furthermore modifications in their pattern of secretion seem to be involved in the improvement of glucose control in obese patients after bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- test meal, glucose and fat
- How many people
- 8 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Mar 2009to Dec 2009
- Phase
- Observational
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy male volunteers
Who may be able to join
- Male
- 18-35 years old
- 19 kg/m2 ≤ BMI ≤ 25 kg/m2
- Healthy
- Low to moderate physical activity
- Non smokers
Who cannot join
- Family history of diabetes mellitus
- Any medication
- Participation to blood spending or other clinical study in the 3 months before the beginning of this study
- Consumption of drugs
- Consumption of more than 50g of alcool in a week
- Vegetarian or particular diet
- Anamnèse d'intolérance alimentaire
- Family history of food intolerance
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Cardiomet Clinical research Center, CHUV
Lausanne, Canton of Vaud, CH-1011
University of Lausanne
Lausanne, 1005
About this study
Official title: Gut Hormone Secretion Pattern in Response to Different Macronutrients in Healthy Volunteers
The role of gut hormone (GLP-1, GIP, PYY...) in glucose homeostasis has been widely demonstrated. Furthermore modifications in their pattern of secretion seem to be involved in the improvement of glucose control in obese patients after bariatric surgery.
The purpose of this study is to assess the respective role of carbohydrate, fat and protein from a complete meal in gut hormones secretion.
Read the detailed description
The study is designed to asses the role of each individual macronutrient of a compete meal in gut hormones secretion in healthy volunteers.
8 healthy young male subjects will be studied on 5 different occasions. To asses the role of each macronutient the subjects will recieve one of the following test meal: a complete sandwich, the proteic part of this complete meal, the glucidic part and the lipidic part. The fifth test will be a fasting test.
To assess the entero-insular axis, a 5.5 hours hyperglycaemic clamp will be performed.
- Conditions
- Healthy Volunteers
- Being tested
- test meal, glucose, fat, protein, control
- Keywords
- Gut hormone, hyperglycaemic clamp, glucose turnver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test mealOther
Mixed meal containing bread, butter, beef
glucoseOther
administration of a glucose meal
fatOther
administration of a lipid meal
proteinOther
administration of a protein meal
controlOther
no meal
| Study group | Role | What they receive |
|---|---|---|
| 1 | Healthy volunteers Receives: Other: test meal; Other: glucose; Other: fat; Other: protein; Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut hormone secretion
Measured: within 4 hours following a test meal
Secondary outcomes (4)
Entero-insular axis measurement
Measured: within 4 hours following a test meal
Glucose turnover
Measured: 6 hours
Insulin sensitivity
Measured: 6 hours
Substrate oxidation
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Responsible party
- Principal investigator, Luc Tappy, MD, University of Lausanne
- Investigators
- Luc Tappy, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869453
- Sponsor's protocol ID
- 162/08/CE/FBM
- Status last verified
- Jun 2012
- First submitted
- 25 Mar 2009
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Carrel G, Egli L, Tran C, Schneiter P, Giusti V, D'Alessio D, Tappy L. Contributions of fat and protein to the incretin effect of a mixed meal. Am J Clin Nutr. 2011 Oct;94(4):997-1003. doi: 10.3945/ajcn.111.017574. Epub 2011 Aug 17.
PubMed 21849595
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Hormone Secretion Pattern in Response to Different Macronutrients in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00869453
- Acronym / sponsor ID
- 162/08/CE/FBM
- Conditions
- Healthy Volunteers
- Keywords
- Gut hormone, hyperglycaemic clamp, glucose turnver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Study start
- Mar 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Mar 2009 (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 role of gut hormone (GLP-1, GIP, PYY...) in glucose homeostasis has been widely demonstrated. Furthermore modifications in their pattern of secretion seem to be involved in the improvement of glucose control in obese patients after bariatric surgery.
The purpose of this study is to assess the respective role of carbohydrate, fat and protein from a complete meal in gut hormones secretion.
Detailed description
The study is designed to asses the role of each individual macronutrient of a compete meal in gut hormones secretion in healthy volunteers.
8 healthy young male subjects will be studied on 5 different occasions. To asses the role of each macronutient the subjects will recieve one of the following test meal: a complete sandwich, the proteic part of this complete meal, the glucidic part and the lipidic part. The fifth test will be a fasting test.
To assess the entero-insular axis, a 5.5 hours hyperglycaemic clamp will be performed.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: test meal, Other: glucose, Other: fat, Other: protein, Other: controlHealthy volunteers |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy male volunteers
Key inclusion criteria (6 listed)
- Male
- 18-35 years old
- 19 kg/m2 ≤ BMI ≤ 25 kg/m2
- Healthy
- Low to moderate physical activity
Key exclusion criteria (8 listed)
- Family history of diabetes mellitus
- Any medication
- Participation to blood spending or other clinical study in the 3 months before the beginning of this study
- Consumption of drugs
- Consumption of more than 50g of alcool in a week
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 mealMixed meal containing bread, butter, beef | Other | 1 |
| glucoseadministration of a glucose meal | Other | 1 |
| fatadministration of a lipid meal | Other | 1 |
| proteinadministration of a protein meal | Other | 1 |
| controlno meal | Other | 1 |
Primary outcome
Gut hormone secretion
Time frame: within 4 hours following a test meal
4 secondary outcomes
Entero-insular axis measurement
Time frame: within 4 hours following a test meal
Glucose turnover
Time frame: 6 hours
Insulin sensitivity
Time frame: 6 hours
Substrate oxidation
Time frame: 6 hours
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 3 Jul 2012.
- Derived from this study: PubMed 21849595Carrel G, Egli L, Tran C, Schneiter P, Giusti V, D'Alessio D, Tappy L. Contributions of fat and protein to the incretin effect of a mixed meal. Am J Clin Nutr. 2011 Oct;94(4):997-1003. doi: 10.3945/ajcn.111.017574. Epub 2011 Aug 17.
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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.
Luc Tappy, MD principal investigator
Centre Hospitalier Universitaire Vaudois
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by University of Lausanne at 2 sites 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 6 inclusion and 8 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 3 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Gut hormone secretion (time frame: within 4 hours following a test meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00869453, which also lists 1 linked publication.
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 3 Jul 2012.