- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00541762
Regulation of Fat-stimulated Neurotensin Secretion in Healthy Subjects
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Basel, Switzerland, CH-4031
- Clinical Research Center, University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy male subjects
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neurotensin plasma concentrations
Time Frame: Change in plasma cocnentrations over 2-3 hours
|
Change in plasma cocnentrations over 2-3 hours
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Collaborators and Investigators
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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EKBB 86/05
- SNF Grant. 3200-065588.04/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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