Intranasal Glucagon and Energy Balance

NCT03650582 | Unknown Phase 2

• 1 other identifier: ING 16-5909
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

food intake; energy expenditure; central nervous system; appetite

Outcome Measures

Primary Outcomes (1)

• Energy Expenditure

  Resting energy expenditure measured by indirect calorimetry

  90 minutes

Secondary Outcomes (2)

• Food intake

  90 minutes

• Appetite

  90 minutes

Study Arms (2)

Glucagon

EXPERIMENTAL

Glucagon, 0.7mg, intranasal, single dose

Drug: Glucagon

Placebo

PLACEBO COMPARATOR

Placebo, intranasal, single dose

Drug: Placebo

Interventions

Glucagon DRUG

Intranasal glucagon

Glucagon

Placebo DRUG

Intranasal placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Glucagon

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Satya Dash, MD

  UHN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Priska Stahel, PhD

CONTACT

416-581-7487; priska.stahel@uhn.ca

Satya Dash, MD

CONTACT

416-340-4800; satya.dash@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blinded study with participant blinded to treatment
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants receive either glucagon or placebo as intranasal spray, in random order on 2 separate study visits, with indirect calorimetry, appetite and food intake assessment

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: August 28, 2018
• Study Start: June 6, 2017
• Primary Completion: September 30, 2018
• Study Completion: October 30, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)