Regulation of Fat-Stimulated Neurotensin Secretion in Healthy Subjects - Full Text View

Sponsored by:	University Hospital, Basel, Switzerland
Information provided by:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00541762

Purpose

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.

Condition	Intervention
Healthy	Dietary Supplement: Fat perfusion to the small intestine

Drug Information available for: Orlistat

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Pharmacokinetics Study
Official Title:	Mechanistic Study (Physiology)

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:

Neurotensin plasma concentrations [ Time Frame: Change in plasma cocnentrations over 2-3 hours ]

Enrollment:	34
Study Start Date:	January 2006
Study Completion Date:	March 2007

Arms	Assigned Interventions
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 witha without DEXLOX or placebo.	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

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male subjects

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541762

Locations

Switzerland
Clinical Research Center, University Hospital
Basel, Switzerland, CH-4031

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Principal Investigator:	Juergen Drewe, MD	University Hospital, 4031 Basel, Switzerland
Principal Investigator:	Christoph Beglinger, MD	Department of Research and Clinical Pharmacology, University Hospital, Basel Switzerland

More Information

Publications:

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.

Study ID Numbers:	EKBB 86/05, SNF Grant. 3200-065588.04/1
Study First Received:	October 8, 2007
Last Updated:	October 9, 2007
ClinicalTrials.gov Identifier:	NCT00541762
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:

Neurotensin
Human
Physiology of neurotensin
fat perfusion
healthy subjects

Study placed in the following topic categories:

Orlistat
Healthy

ClinicalTrials.gov processed this record on January 14, 2009