Gut Hormone Secretion and Macronutrients - Full Text View

Sponsors and Collaborators:	University of Lausanne Centre Hospitalier Universitaire Vaudois
Information provided by:	University of Lausanne
ClinicalTrials.gov Identifier:	NCT00869453

Purpose

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.

Condition	Intervention
Healthy Volunteers	Other: test meal

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Gut Hormone Secretion Pattern in Response to Different Macronutrients in Healthy Volunteers

Further study details as provided by University of Lausanne:

Primary Outcome Measures:

Gut hormone secretion [ Time Frame: within 4 hours following a test meal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Entero-insular axis measurement [ Time Frame: within 4 hours following a test meal ] [ Designated as safety issue: No ]
Glucose turnover [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Insulin sensitivity [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Substrate oxidation [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	8
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Healthy volunteers	Other: test meal Mixed meal containing bread, butter, beef

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.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Healthy male volunteers

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869453

Contacts

Contact: Luc TAPPY, MD

0041216925541

luc.tappy@unil.ch

Locations

Switzerland
University of Lausanne	Active, not recruiting
Lausanne, Switzerland, 1005
Switzerland, VD
Cardiomet Clinical research Center, CHUV	Recruiting
Lausanne, VD, Switzerland, CH-1011
Contact: Philippe Schneiter, PhD +41 21 692 55 69 philippe.schneiter@unil.ch

Sponsors and Collaborators

University of Lausanne

Centre Hospitalier Universitaire Vaudois

Investigators

Principal Investigator:

Luc Tappy, MD

Centre Hospitalier Universitaire Vaudois

More Information

No publications provided

Responsible Party:	University of Lausanne ( Prof Luc Tappy, MD )
Study ID Numbers:	162/08/CE/FBM
Study First Received:	March 25, 2009
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00869453 History of Changes
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University of Lausanne:

Gut hormone
hyperglycaemic clamp
glucose turnver

Study placed in the following topic categories:

Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Healthy
Hormones

Additional relevant MeSH terms:

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009