HealthyNCT00541762
Regulation of Fat-stimulated Neurotensin Secretion in Healthy Subjects
A study testing Fat perfusion to the small intestine in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fat perfusion to the small intestine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2006to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinical Research Center, University Hospital
Basel, CH-4031
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Fat perfusion to the small intestine
- Keywords
- Neurotensin, Human, Physiology of neurotensin, fat perfusion, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat perfusion to the small intestineDietary supplement
- 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
| Study group | Role | What they receive |
|---|---|---|
| A, 3; B, 3; C, 3 | Other | 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. Receives: Dietary Supplement: Fat perfusion to the small intestine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurotensin plasma concentrations
Measured: Change in plasma cocnentrations over 2-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startJan 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juergen Drewe, MD, Principal investigator, University Hospital, 4031 Basel, SwitzerlandChristoph Beglinger, MD, Principal investigator, Department of Research and Clinical Pharmacology, University Hospital, Basel Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541762
- Sponsor's protocol ID
- EKBB 86/05
- Other IDs
- SNF Grant. 3200-065588.04/1
- Status last verified
- Mar 2015
- First submitted
- 8 Oct 2007
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/0167-0115(85)90191-0.
PubMed 3840906
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Study (Physiology)
- ClinicalTrials.gov ID
- NCT00541762
- Acronym / sponsor ID
- EKBB 86/05
- Conditions
- Healthy
- Keywords
- Neurotensin, Human, Physiology of neurotensin, fat perfusion, healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 10 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A, 3; B, 3; C, 3 | Other | Dietary Supplement: Fat perfusion to the small intestineA, 3: Fat with and without orlistat or placebo. B, 3: LCF vs MCF vs placebo. C, 3: LCF with and without DEXLOX or placebo. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male subjects
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fat perfusion to the small intestine1. 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 | Dietary supplement | A, 3; B, 3; C, 3 |
Primary outcome
Neurotensin plasma concentrations
Time frame: Change in plasma cocnentrations over 2-3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Background: PubMed 3840906Ferris 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. doi: 10.1016/0167-0115(85)90191-0.
- publication in JCEMLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juergen Drewe, MD principal investigator
University Hospital, 4031 Basel, Switzerland
Christoph Beglinger, MD principal investigator
Department of Research and Clinical Pharmacology, University Hospital, Basel Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fat perfusion to the small intestine in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurotensin plasma concentrations (time frame: Change in plasma cocnentrations over 2-3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00541762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.