NCT03141827

Brief Summary

This study compares the effect of insulin given as a nasal spray with a placebo. Insulin is a chemical messenger (hormone) in the body that controls fat (triglyceride) levels in the blood by controlling the amount of fat made by the liver and gut. Recent research suggests that insulin may work through the brain. The investigators hypothesize that preferential delivery of insulin into the brain, through nasal spray of the hormone, may affect the amount of fats made by the liver and gut.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2016

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

April 14, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

10 months

First QC Date

May 3, 2017

Last Update Submit

May 4, 2017

Conditions

Hyperlipidemia

Keywords

LipoproteinApolipoproteinPancreatic clampInsulinNasal

Outcome Measures

Primary Outcomes (1)

  • Triglyceride-rich lipoprotein apolipoprotein B100 production rate

    Triglyceride-rich lipoprotein apolipoprotein B100 production rate will be measured following nasal spray of insulin or placebo

    10 hours

Secondary Outcomes (1)

  • Triglyceride-rich lipoprotein apolipoprotein B48 production rate

    10 hours

Study Arms (2)

Insulin

EXPERIMENTAL

Nasal spray, insulin 40 IU, single dose

Drug: Insulin

Placebo

PLACEBO COMPARATOR

Nasal spray, placebo, single dose

Drug: Placebo

Interventions

InsulinDRUG

Insulin 40 IU, nasal spray, single dose

Insulin
PlaceboDRUG

Placebo, nasal spray, single dose

Placebo

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 to 40 kg/m2
  • Hemoglobin in the normal range.
  • Normal glucose tolerance in response to a 75g, 2-hr oral glucose tolerance test
  • Women of reproductive age should be on contraception (oral contraceptive pill or intra-uterine device/coil) for at least 2 months prior to and after the study.

You may not qualify if:

  • Study participant with a history of hepatitis/hepatic disease that has been active within the previous two years.
  • Any current or previous history of biliary disease (including gall stones, biliary atresia and cholecystitis) or pancreatitis.
  • Any current or previous history of endocrine disease, dyslipidemia or malignancy
  • 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 hyper/ hypotension (sitting diastolic pressure \> 100 or systolic \> 180 or systolic pressure \<100) or proliferative retinopathy
  • Use of immunosuppressive agents at any time during the study
  • Allergy to any study medication
  • Pregnancy or breastfeeding
  • Heavy smoker
  • Fasting blood glucose \> 6.0 mmol/l or known diabetes.
  • 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 nasal pathology.
  • Any laboratory values: aspartate aminotransferase \> 2x upper limit of normal ; alanine aminotransferase \> 2x upper limit of normal; thyroid-stimulating hormone \> 6 milliunit per litre

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tornto General Hospital, UHN

Toronto, Ontario, M5G 1L7, Canada

Location

Related Publications (1)

  • Xiao C, Dash S, Stahel P, Lewis GF. Effects of Intranasal Insulin on Triglyceride-Rich Lipoprotein Particle Production in Healthy Men. Arterioscler Thromb Vasc Biol. 2017 Sep;37(9):1776-1781. doi: 10.1161/ATVBAHA.117.309705. Epub 2017 Jul 27.

    PMID: 28751575DERIVED

MeSH Terms

Conditions

HyperlipidemiasInsulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinismGlucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Gary F Lewis, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 5, 2017

Study Start

April 14, 2016

Primary Completion

February 15, 2017

Study Completion

April 26, 2017

Last Updated

May 8, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)