NCT00541762

Brief Summary

Context: Cholecystokinin (CCK) and neurotensin are stimulated during meal intake by the presence of fat in the small intestine. The sequence of events suggests that fat hydrolysis is crucial for triggering the release. Objectives: The aim of this study was therefore to investigate whether CCK mediated the effect of intraduodenal (ID) fat on neurotensin secretion via CCK-1 receptors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

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

January 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

October 8, 2007

Last Update Submit

March 9, 2015

Conditions

Healthy

Keywords

NeurotensinHumanPhysiology of neurotensinfat perfusionhealthy subjects

Outcome Measures

Primary Outcomes (1)

  • Neurotensin plasma concentrations

    Change in plasma cocnentrations over 2-3 hours

Study Arms (1)

A, 3; B, 3; C, 3

OTHER

A, 3: Fat with and without orlistat or placebo. B, 3: LCF vs MCF vs placebo. C, 3: LCF with and without DEXLOX or placebo.

Dietary Supplement: Fat perfusion to the small intestine

Interventions

Fat perfusion to the small intestineDIETARY_SUPPLEMENT

1. Triglycerides, long chain fatty acids, medium chain fatty acids perfused to the small intestine 2. Orlistat perfused to the small intestine 3. DEXLOX as CCK-1 receptor antagonist

A, 3; B, 3; C, 3

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center, University Hospital

Basel, CH-4031, Switzerland

Location

Related Publications (1)

  • Ferris CF, Carraway RE, Hammer RA, Leeman SE. Release and degradation of neurotensin during perfusion of rat small intestine with lipid. Regul Pept. 1985 Oct;12(2):101-11. doi: 10.1016/0167-0115(85)90191-0.

    PMID: 3840906BACKGROUND

Related Links

Study Officials

  • Juergen Drewe, MD

    University Hospital, 4031 Basel, Switzerland

    PRINCIPAL INVESTIGATOR

  • Christoph Beglinger, MD

    Department of Research and Clinical Pharmacology, University Hospital, Basel Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2007

First Posted

October 10, 2007

Study Start

January 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

CH(1)