Text Size

Regulation of Fat-stimulated Neurotensin Secretion in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00541762
First received: October 8, 2007
Last updated: April 6, 2010
Last verified: April 2010
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
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 with and without DEXLOX or placebo.
 Dietary Supplement: 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

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

Additional Information:
publication in JCEM  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00541762     History of Changes
Other Study ID Numbers: EKBB 86/05, SNF Grant. 3200-065588.04/1
Study First Received: October 8, 2007
Last Updated: April 6, 2010
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
Neurotensin
Human
Physiology of neurotensin
fat perfusion
healthy subjects

ClinicalTrials.gov processed this record on May 21, 2013