Trial · Interventional
CompletedPhase 2/3Registry dataL-NMMA on GLP-2 Mediated Intestinal Lipoprotein Release
Short name LNMMA
Overview
- Status
- Completed
- Phase
- Phase 2/3
- Enrollment
- 10 participants (actual)
- Sponsor
- University Health Network, Toronto · Other
- Design
- Randomized · Single masking
- Countries
1 country
Canada
- Start
- 27 Sept 2017
- Primary completion
- 20 Mar 2019
- Completion
- 20 Mar 2019
- First posted
- 23 May 2018
- Last update posted
- 27 Mar 2020
- Conditions
- Hyperlipidemias
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2/3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The gut is able to retain some fat for many hours after a fatty meal. The gut hormone glucagon-like peptide-2 (GLP-2) is known to release these fat stores in the gut, but it is not known how GLP-2 achieves this. One possibility is that GLP-2 increases blood flow in the gut. NG-monomethyl-L-arginine (L-NMMA) is a substance that inhibits nitric oxide synthase (an enzyme that helps make nitric oxide which increases blood flow). This protocol examines whether blocking gut blood flow with L-NMMA is able to prevent GLP-2 from releasing gut lipid stores. Healthy participants will be treated with a combination of Teduglutide (a resistant form of GLP-2) and L-NMMA, and their respective controls. Blood lipid levels will be measured following treatments.
Interventions
- Teduglutide + Normal SalineDrug
- Teduglutide + L-NMMADrug
- Placebo + L-NMMADrug
Arms3
Placebo comparator
Teduglutide + Normal Saline
Teguglutide + (L-NMMA control)
Active comparator
Teduglutide + L-NMMA
Tedulgutide + L-NMMA
Placebo comparator
Placebo + L-NMMA
(Teduglutide control) + L-NMMA
Primary outcomes1
Outcomes the sponsor listed as primary.
Plasma Lipid Levels
Time frame · 10.5 hours
Registry description
Lipid levels in plasma and lipoprotein fractions are measured following treatments
Secondary outcomes(1)
Blood Flow
Time frame · 3 hours
Registry description
Mesenteric blood flow rates are measured with ultrasound following treatments
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 60 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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