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Trial · Interventional

CompletedPhase 2/3Registry data

L-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
2017201820192020
  1. Ph 2/3

    LNMMA

    NCT03534661

    27 Sept 2017 to 20 Mar 2019

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.

  1. Plasma Lipid Levels

    Time frame · 10.5 hours

    Registry description

    Lipid levels in plasma and lipoprotein fractions are measured following treatments

Secondary outcomes(1)
  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
Inclusion Criteria: * Men and women, aged 18 to 60 years * Body mass index 20 kg/m2 to 30 kg/m2 * Hemoglobin above 130g/L. * Normal glucose tolerance in response to a 75g, 2-hr oral glucose tolerance test Exclusion Criteria: * Subject has a history of hepatitis/hepatic disease that has been active within the previous two years. * Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (creatinine \> 1.5 mg/dL), genitourinary, hematological systems, or has severe uncontrolled treated or untreated hypertension (sitting diastolic blood pressure \> 100 or systolic \> 180) or proliferative retinopathy * History of diabetes or oral glucose tolerance indicative of diabetes or impaired glucose tolerance. * Any history of a myocardial infarction or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on electrocardiogram, unstable angina, or decompensated heart failure. * Any laboratory values: aspartate transaminase \> 2x upper limit of normal; alanine aminotransferase \> 2x upper limit of normal; thyroid-stimulating hormone \> 6 miliunit/l * Current addiction to alcohol or substances of abuse as determined by the investigator. * Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation * Taking any prescription or non-prescription medications at the time of the study * Having donated blood three months prior to and three months post study procedures * A pregnancy test will be performed 1 to 3 days prior to each study in all female research participants. Those who test positive for pregnancy will be excluded.

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