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Trial record 52 of 69 for:    ORLISTAT

Regulation of Fat-stimulated Neurotensin Secretion in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00541762
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE October 8, 2007
First Posted Date  ICMJE October 10, 2007
Last Update Posted Date March 10, 2015
Study Start Date  ICMJE January 2006
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2007)
Neurotensin plasma concentrations [ Time Frame: Change in plasma cocnentrations over 2-3 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00541762 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Regulation of Fat-stimulated Neurotensin Secretion in Healthy Subjects
Official Title  ICMJE Mechanistic Study (Physiology)
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Dietary Supplement: Fat perfusion to the small intestine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2007)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00541762
Other Study ID Numbers  ICMJE EKBB 86/05
SNF Grant. 3200-065588.04/1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University Hospital, Basel, Switzerland
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP