NCT03534661

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2019

Enrollment Period

1.5 years

First QC Date

May 11, 2018

Last Update Submit

March 26, 2020

Conditions

Hyperlipidemias

Outcome Measures

Primary Outcomes (1)

  • Plasma Lipid Levels

    Lipid levels in plasma and lipoprotein fractions are measured following treatments

    10.5 hours

Secondary Outcomes (1)

  • Blood Flow

    3 hours

Study Arms (3)

Teduglutide + Normal Saline

PLACEBO COMPARATOR

Teguglutide + (L-NMMA control)

Drug: Teduglutide + Normal Saline

Teduglutide + L-NMMA

ACTIVE COMPARATOR

Tedulgutide + L-NMMA

Drug: Teduglutide + L-NMMA

Placebo + L-NMMA

PLACEBO COMPARATOR

(Teduglutide control) + L-NMMA

Drug: Placebo + L-NMMA

Interventions

Teduglutide + Normal SalineDRUG

Teduglutide 0.05 mg/kg subcutaneous injection; Normal Saline intravenous infusion

Also known as: L-NMMA control
Teduglutide + Normal Saline
Teduglutide + L-NMMADRUG

Teduglutide 0.05 mg/kg subcutaneous injection; L-NMMA 10 mg/kg intravenous infusion

Also known as: active treatments
Teduglutide + L-NMMA
Placebo + L-NMMADRUG

Placebo subcutaneous injection; L-NMMA 10 mg/kg intravenous infusion

Also known as: Teduglutide control
Placebo + L-NMMA

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tornto General Hospital, UHN

Toronto, Ontario, M5G 1L7, Canada

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

teduglutideSaline Solutionomega-N-Methylarginine

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsArginineAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single-blinded for participants
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Each participant receives 3 randomized treatments.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 23, 2018

Study Start

September 27, 2017

Primary Completion

March 20, 2019

Study Completion

March 20, 2019

Last Updated

March 27, 2020

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)