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...
Date First Received: October 8, 2007
Last Updated: October 9, 2007
Verified by: University Hospital, Basel, Switzerland, August 2007
Clinical Trial Phase: N/A | Start Date: January 2006
Overall Status: Completed
Estimated Enrollment: 34
Brief Summary
Official Title: “Mechanistic Study (Physiology)”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Basic Science, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Pharmacokinetics Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- 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
Arms, Groups and Cohorts in this Clinical Trial
- Other: 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.
Outcome Measures for this Clinical Trial
Primary Measures
- Neurotensin plasma concentrations
- Time Frame: Change in plasma cocnentrations over 2-3 hours
- Time Frame: Change in plasma cocnentrations over 2-3 hours
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Healthy male subjects
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 35 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: University Hospital, Basel, Switzerland
Overall Clinical Trial Officials and Contacts
Juergen Drewe, MD Principal Investigator University Hospital, 4031 Basel, Switzerland
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00541762
Study ID Number: EKBB 86/05
ClinicalTrials.gov Identifier: NCT00541762
Health Authority: Switzerland: Swissmedic
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