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INGEB: Intranasal Glucagon and Energy Balance

Sponsor
University Health Network, Toronto (Other)
Overall Status
Unknown status
CT.gov ID
NCT03650582
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
16.8
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

People who are overweight often find it difficult to lose weight through diet and medications because weight loss reduces the amount of energy spent by the body and increases appetite. Glucagon, when given as an injection, reduces appetite and increases the amount of energy spent by the body, even when resting. Based on studies in animals, it does so by working on the brain. However, when gives as an injection it raises blood sugar levels by acting on the liver and therefore it is not used as a weight loss drug. It has previously been shown that hormones such as glucagon, when given as a spray through the nose, can reach the brain with no major effect on the liver. Importantly it does not increase blood sugar. In this study the research team is investigating whether nasal glucagon reduces appetite and increases energy spent by the body compared to a placebo spray. If it does, it may be a potential treatment for losing weight.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

Resting energy expenditure, appetite and food intake is being investigated in up to 20 individuals. Participants are their own control in a single-blind, placebo-controlled, crossover design. Participants are admitted after an overnight fast and allowed to rest for 1 hour before either intranasal glucagon (0.7mg) or intranasal placebo (sterile diluent) is administered. Study visits occur 1-3 weeks apart with intranasal glucagon or placebo applied in random order. Resting energy expenditure is measured via indirect calorimetry at baseline and over 90 minutes post-spray in 10-20 minute segments. Blood samples are taken at baseline and at regular intervals post-spray to measure glucagon, glucose and other hormones/metabolites. Appetite is assessed by visual analogue scale at 90 minutes post-spray followed by provision of a buffet-style meal for ad libitum food intake measurement.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants receive either glucagon or placebo as intranasal spray, in random order on 2 separate study visits, with indirect calorimetry, appetite and food intake assessmentParticipants receive either glucagon or placebo as intranasal spray, in random order on 2 separate study visits, with indirect calorimetry, appetite and food intake assessment
Masking:
Single (Participant)
Masking Description:
Single-blinded study with participant blinded to treatment
Primary Purpose:
Basic Science
Official Title:
Assessing the Effects of Intranasal Glucagon on Energy Balance in Humans
Actual Study Start Date :
Jun 6, 2017
Anticipated Primary Completion Date :
Sep 30, 2018
Anticipated Study Completion Date :
Oct 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Glucagon

Glucagon, 0.7mg, intranasal, single dose

Drug: Glucagon
Intranasal glucagon
Placebo Comparator: Placebo

Placebo, intranasal, single dose

Drug: Placebo
Intranasal placebo

Outcome Measures

Primary Outcome Measures

  1. Energy Expenditure [90 minutes]

    Resting energy expenditure measured by indirect calorimetry

Secondary Outcome Measures

  1. Food intake [90 minutes]

    Ad libitum food intake

  2. Appetite [90 minutes]

    Appetite assessed by visual analogue scale ranging from 0 to 10 where 0 indicates no appetite and 10 indicates the highest appetite

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Body mass index 25- 40 kg/m2

  • Hemoglobin in the normal range

  • Normal fasting glucose and HbA1C

  • Women of reproductive age should be on contraception (oral contraceptive pill or intra-uterine device/coil) for at least 1 month prior to and after the study.

Exclusion Criteria:

  • Any history of heart disease or clinically significant, active, cardiovascular history

  • Study participant with active hepatic disease (except hepatic steatosis which is frequently seen in overweight/obese individuals)

  • Any current or previous history of biliary disease (including gall stones, biliary atresia and cholecystitis) or pancreatitis.

  • Any current or previous history of malignancy

  • 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).

  • Allergy to any study medication

  • Pregnancy or breastfeeding

Contacts and Locations

Locations

Site City State Country Postal Code
1 Toronto General Hospital Toronto Ontario Canada M5G 2C4

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Satya Dash, MD, UHN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT03650582
Other Study ID Numbers:
  • ING 16-5909
First Posted:
Aug 28, 2018
Last Update Posted:
Aug 31, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Health Network, Toronto
food intake
energy expenditure
central nervous system
appetite
Additional relevant MeSH terms:
Glucagon

Study Results

No Results Posted as of Aug 31, 2018