Regulation of Fat-stimulated Neurotensin Secretion in Healthy Subjects

NCT ID: NCT00541762

Last Updated: 2015-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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Setting: Single center study; 34 male volunteers were studied in consecutive, randomized, double blind, crossover studies.

Subjects and Methods: CCK and neurotensin release were quantified in: 1) 12 subjects receiving an ID fat infusion with or without 60 mg orlistat, an irreversible inhibitor of gastrointestinal lipases, in comparison to vehicle. 2) 12 subjects receiving ID long chain fatty acids (LCF), ID medium chain fatty acids (MCF) or ID vehicle. 3) 10 subjects receiving ID LCF with and without the CCK-1 receptor antagonist dexloxiglumide (DEXLOX) or ID vehicle plus IV saline (placebo). Hormone concentrations were measured by specific RIA systems.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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A, 3; B, 3; C, 3

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.

Group Type OTHER

Fat perfusion to the small intestine

Intervention Type DIETARY_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

Interventions

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Fat perfusion to the small intestine

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juergen Drewe, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, 4031 Basel, Switzerland

Christoph Beglinger, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Clinical Research Center, University Hospital

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 3840906 (View on PubMed)

Related Links

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Other Identifiers

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SNF Grant. 3200-065588.04/1

Identifier Type: -

Identifier Source: secondary_id

EKBB 86/05

Identifier Type: -

Identifier Source: org_study_id

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