- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00869453
Gut Hormone Secretion and Macronutrients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Lausanne, Switzerland, 1005
- University of Lausanne
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-
VD
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Lausanne, VD, Switzerland, CH-1011
- Cardiomet Clinical research Center, CHUV
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male
- 18-35 years old
- 19 kg/m2 ≤ BMI ≤ 25 kg/m2
- Healthy
- Low to moderate physical activity
- Non smokers
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Healthy volunteers
|
Mixed meal containing bread, butter, beef
administration of a glucose meal
administration of a lipid meal
administration of a protein meal
no meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Gut hormone secretion
Time Frame: within 4 hours following a test meal
|
within 4 hours following a test meal
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Entero-insular axis measurement
Time Frame: within 4 hours following a test meal
|
within 4 hours following a test meal
|
|
Glucose turnover
Time Frame: 6 hours
|
6 hours
|
|
Insulin sensitivity
Time Frame: 6 hours
|
6 hours
|
|
Substrate oxidation
Time Frame: 6 hours
|
6 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Luc Tappy, MD, Centre Hospitalier Universitaire Vaudois
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 162/08/CE/FBM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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