NCT00869453

Brief 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. The purpose of this study is to assess the respective role of carbohydrate, fat and protein from a complete meal in gut hormones secretion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2009

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

March 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 3, 2012

Status Verified

June 1, 2012

Enrollment Period

5 months

First QC Date

March 25, 2009

Last Update Submit

June 29, 2012

Conditions

Healthy Volunteers

Keywords

Gut hormonehyperglycaemic clampglucose turnver

Outcome Measures

Primary Outcomes (1)

  • Gut hormone secretion

    within 4 hours following a test meal

Secondary Outcomes (4)

  • Entero-insular axis measurement

    within 4 hours following a test meal

  • Glucose turnover

    6 hours

  • Insulin sensitivity

    6 hours

  • Substrate oxidation

    6 hours

Study Arms (1)

1

Healthy volunteers

Other: test mealOther: glucoseOther: fatOther: proteinOther: control

Interventions

test mealOTHER

Mixed meal containing bread, butter, beef

1
glucoseOTHER

administration of a glucose meal

1
fatOTHER

administration of a lipid meal

1
proteinOTHER

administration of a protein meal

1
controlOTHER

no meal

1

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy male volunteers

You may qualify if:

  • Male
  • years old
  • kg/m2 ≤ BMI ≤ 25 kg/m2
  • Healthy
  • Low to moderate physical activity
  • Non smokers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cardiomet Clinical research Center, CHUV

Lausanne, Canton of Vaud, CH-1011, Switzerland

Location

University of Lausanne

Lausanne, 1005, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 21849595DERIVED

MeSH Terms

Interventions

GlucoseCD36 AntigensProteins

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesPlatelet Membrane GlycoproteinsMembrane GlycoproteinsGlycoproteinsGlycoconjugatesFatty Acid Transport ProteinsMembrane Transport ProteinsCarrier ProteinsAmino Acids, Peptides, and ProteinsMembrane ProteinsReceptors, Cell SurfaceReceptors, ImmunologicScavenger Receptors, Class BReceptors, ScavengerReceptors, LDLReceptors, Lipoprotein

Study Officials

  • Luc Tappy, MD

    Centre Hospitalier Universitaire Vaudois

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of physiology

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

March 1, 2009

Primary Completion

August 1, 2009

Study Completion

December 1, 2009

Last Updated

July 3, 2012

Record last verified: 2012-06

Locations

CH(2)