Assessment of Intranasal Glucagon on Endogenous Glucose Production

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

Peripheral glucagon action increases hepatic glucose production. In rodents hypothalamic action of glucagon paradoxically suppresses glucose production. Intranasally administered peptides have been shown to preferentially enter the central nervous system. We assessed the effects of intranasal glucagon on hepatic glucose production

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Glucagon; Glucagon-Like Peptide 1

Criteria

Inclusion Criteria:

• 1. Men and women, aged 18 to 60 years 2. Body mass index 20 to 27 kg/m2 3. Hemoglobin in the normal range. 4. Normal glucose tolerance in response to a 75gram glucose

Exclusion Criteria:

• 1. Study participant with a history of hepatitis/hepatic disease that has been active within the previous two years.

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

3. 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, genitourinary, hematological systems, or has severe uncontrolled treated or untreated hyper/ hypotension (sitting diastolic > 100 or systolic > 180 or systolic<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. Fasting blood glucose > 6.0 mmol/l or known diabetes. 10. 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.

11. Any nasal pathology. 12. Abnormal liver and thyroid function 13. Current addiction to alcohol or substances of abuse as determined by the investigator or of any mental illness.

14. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation 15. 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.

16. Will not donate blood three months prior to and three months post study procedures