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NCT00541762 Clinical Trial

Regulation of Fat-stimulated Neurotensin Secretion in Healthy Subjects

Healthy Clinical Trial

Official title:
Mechanistic Study (Physiology)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00541762
Other study ID # EKBB 86/05
Secondary ID SNF Grant. 3200-
Status Completed
Phase N/A
First received October 8, 2007
Last updated March 9, 2015
Start date January 2006
Est. completion date March 2007

Study information
Verified date March 2015
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Healthy male subjects

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Fat perfusion to the small intestine
Triglycerides, long chain fatty acids, medium chain fatty acids perfused to the small intestine Orlistat perfused to the small intestine DEXLOX as CCK-1 receptor antagonist

Locations
Country Name City State
Switzerland Clinical Research Center, University Hospital Basel

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Neurotensin plasma concentrations Change in plasma cocnentrations over 2-3 hours
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