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Regulation of Fat-stimulated Neurotensin Secretion in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00541762
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : March 10, 2015
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Fat perfusion to the small intestine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Mechanistic Study (Physiology)
Study Start Date : January 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Neurotensin plasma concentrations [ Time Frame: Change in plasma cocnentrations over 2-3 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male subjects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00541762

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Clinical Research Center, University Hospital
Basel, Switzerland, CH-4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
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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
Additional Information:
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Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT00541762    
Other Study ID Numbers: EKBB 86/05
SNF Grant. 3200-065588.04/1
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015
Keywords provided by University Hospital, Basel, Switzerland:
Physiology of neurotensin
fat perfusion
healthy subjects