NCT02131948

CompletedPhase 1

Regulation of Endogenous Glucose Production by Brain Insulin...

University Health Network, Toronto Source

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Other study identifiers

Sponsor study identifier

REB 12-5032A

Study Type

interventional

Actual enrollment (reported)

8

Locations

1 country

Sites

1

Timeline

Study Start

November 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2014

Actual (reported)

Study Completion

July 2014

Actual (reported)

Brief Summary

It is well known that the hormone insulin lowers blood glucose in part by acting directly on the liver and reducing hepatic glucose production. Animal studies have shown that the hormone insulin can act on the brain to indirectly lower glucose production by the liver. We aim to test whether this is true in humans by giving insulin intranasally. It has previously been shown that a nasal spray can deliver insulin directly to the brain without affecting circulating insulin concentration.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 8 participants
Study completion date: July 2014
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2013
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
May 2, 2014
Actual (reported)
First Posted
May 6, 2014
Actual (reported)
Primary Completion
July 2014
Actual (reported)
Study Completion
July 2014
Actual (reported)

Last Updated: December 2, 2015
Status Verified: November 2015
Last Update Submitted: November 30, 2015

Conditions

Insulin Resistance, Diabetes

Keywords

Insulin resistanceBrain insulin actionType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

Endogenous glucose production
Effects of intranasal insulin and placebo on endogenous glucose production will be assessed
8 hours

Study Arms (2)

Intranasal insulin

EXPERIMENTAL

40 IU of intranasal insulin

Drug: Intranasal insulin

Intranasal placebo

PLACEBO COMPARATOR

Placebo comparator to intranasal insulin

Drug: Intranasal placebo

Interventions

Intranasal insulinDrug

Intranasal spray

Also known as: Humalog lispro 40 IU intranasally

Intranasal insulin

Intranasal placeboDrug

Intranasal spray

Also known as: Diluent intranasally

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 20-27.

Sponsors & Collaborators

University Health Network, Toronto
Otherlead

Study Sites (1)

Tornto General Hospital, UHN

Toronto, Ontario, M5G 1L7, Canada

MeSH Terms

Conditions

Insulin ResistanceDiabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Enrollment

8 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
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 2, 2014

First Posted

May 6, 2014

Study Start

November 2013

Date type not reported

This date has not been verified as actual or estimated.

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Intranasal placebo

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.

Volunteers who have taken part in the study with the previously approved protocol will be eligible to participate in the amended study, if they provide their informed consent

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 4. Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr \> 1.5 mg/dL) genitourinary, hematological systems, or has severe uncontrolled treated or untreated hyper/ hypotension (sitting diastolic BP \> 100 or systolic \> 180 or systolic BP\<100) or proliferative retinopathy 5. Use of immunosuppressive agents at any time during the study 6. Allergy to any study medication 7. Pregnancy or breastfeeding 8. Heavy smoker 9. Prior nasoduodenal tube insertion under fluoroscopic guidance. 10. Fasting blood glucose \> 6.0 mmol/l or known diabetes. 11. Any history of a MI or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ECG, unstable angina, or decompensated heart failure.
\. Any nasal pathology likely to affect absorption of insulin or insertion of nasoduodenal tube.
\. Any laboratory values: AST \> 2x ULN; ALT \> 2x ULN TSH \> 6 mU/l 14. Current addiction to alcohol or substances of abuse as determined by the investigator.
\. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation 16. Taking any regular prescription or non-prescription medications at the time of the study. Occasional use of medications such as acetoaminophen or Tylenol 1 or any use of natural health products may be permitted at the discretion of the investigator.
\. Will not donate blood three months prior to and three months post study procedures

Contact the study team to confirm eligibility.

Primary Completion

July 2014

Actual (reported)

Study Completion

July 2014

Actual (reported)

Last Updated

December 2, 2015

Record last verified: 2015-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02131948
Data provider: ClinicalTrials.gov
Source updated: 2015-12-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:19 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Intranasal insulin

Intranasal placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations