Regulation of Fat-stimulated Neurotensin Secretion in Healthy Subjects

Official Title: “Mechanistic Study (Physiology)”

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.

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 with and without DEXLOX or placebo.

Primary Measures

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

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

Lead Investigator: University Hospital, Basel, Switzerland Other

Overall Clinical Trial Officials and Contacts

Juergen Drewe, MD Principal Investigator University Hospital, 4031 Basel, Switzerland  

Information obtained from ClinicalTrials.gov on February 12, 2012

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

publication in JCEM