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GIO: To Determine Tolerability to Glucagon Infusion in Obese Subjects

Sponsor
AdventHealth Translational Research Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02817659
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
67
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To further understand the tolerability of glucagon.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

To determine the tolerability of glucagon infusion administered in an escalating step-wise manner in healthy obese subjects

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Pilot Study to Determine Tolerability to Glucagon Infusion in Obese Subjects
Actual Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Jan 13, 2017
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Glucagon Infusion

Glucagon infusion in escalating manner at 12.5, 25, 37.5 and 50 ng/kg/min (each step for 60 min). At 30 and 60 mins of each infusion rate, we will administer a previously established questionnaire to assess overall nausea intensity.

Drug: Glucagon
Glucagon infusion

Outcome Measures

Primary Outcome Measures

  1. Measure glucagon tolerance in healthy obese subject prior to subject becoming significantly nauseous. [Visit 1, measured at 30 minutes]

    Glucagon infused in escalating manner. Each dose administered for 60 minutes. Intensity of nausea measured by administering a questionnaire that measures overall nausea intensity.

  2. Measure glucagon tolerance in healthy obese subject prior to subject becoming significantly nauseous. [Visit 1, measured at 60 minutes]

    Glucagon infused in escalating manner. Each dose administered for 60 minutes. Intensity of nausea measured by administering a questionnaire that measures overall nausea intensity.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Age 18-55 years, inclusive

  2. BMI ≥27 to ≤40 kg/m2

  3. Stable body weight for 3 months (self-reported loss/gain <5%)

  4. Subject is judged to be non-diabetic and in good health on the basis of medical history, physical examination, electrocardiogram, and routine laboratory data

  5. Subject understands the procedures and agrees to participate in the study program by giving written informed consent, and is willing to comply with the trial restrictions

  6. Subject is willing to avoid alcohol consumption for 48 hours prior to the inpatient study visit

  7. Subject is willing to avoid consumption of caffeine and caffeinated beverages for 24 hours prior to the inpatient study visit

  8. Subject is willing to avoid strenuous physical activity for 72 hours prior to the inpatient study visit

  9. Female subjects of child bearing potential must be willing to use acceptable birth control during study participation (oral contraceptives, intrauterine device, implanted or injectable contraceptives, abstinence).

Exclusion Criteria:

  1. Treatment with any medication known to significantly impact body weight (e.g., weight loss medications, atypical antipsychotics) within 3 months prior to screening except for stable physiological hormone replacement therapy (i.e., thyroid hormone, estrogen)

  2. History of bariatric surgery

  3. Current liver, renal, pulmonary, cardiac, oncologic, metabolic, gastrointestinal or hematologic disease which the Investigator believes is clinically significant, including:

  4. Liver disease or liver injury as indicated by abnormal liver function tests (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase , serum bilirubin) >3 × upper limit of normal (ULN), or history of hepatic cirrhosis

  5. History or presence of impaired renal function as indicated by an estimated glomerular filtration rate <60 ml/hr or urine albumin-to-creatinine ratio >35 mg/mmol

  6. Significant cardiovascular disease, including Class III or greater congestive heart failure (CHF), coronary artery disease, second degree or greater heart block, or clinically significant arrhythmias; baseline second degree or greater heart block or prolonged QT syndrome (QTc interval ≥ 470 msec); or any major cardiovascular event within the last 3 years (including myocardial infarction, transient ischemic attack [TIA], cerebrovascular accident [CVA], angina, and hospitalization due to CHF, transient ischemic attack (TIA), and CVA)

  7. Metabolic, other or endocrine disorders, including diagnosis of type 1 or type 2 diabetes mellitus [HbA1c ≥6.5%]), inadequately treated hyperthyroidism (thyroid stimulating hormone [TSH] below normal range) or hypothyroidism (TSH above upper limit of normal if symptomatic or TSH >10 U/mL), Cushing syndrome, Addison's disease, hypogonadism, or genetic disorders linked to obesity

  8. History of irritable bowel disease, recurrent nausea or vomiting

  9. Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women)

  10. Self-reported history of hepatitis B, hepatitis C, or HIV

  11. History of recurrent sleep disturbances and/or prone to sleep disturbances based on lifestyle or employment (e.g., variable work schedule, overnight shift work, etc.)

  12. Diagnosis of sleep apnea with or without use of (continuous positive airway pressure)

  13. Major surgery within last 3 months

  14. Blood donation within 4 weeks prior to the screening visit

  15. Participation in another investigational trial within 4 weeks prior to the screening visit. The 4 week window will be derived from the date of the last trial medication and/or blood collection in a previous trial and/or adverse event (AE) related to trial drug to the screening visit of the current trial.

  16. Illicit drug abuse or use of nicotine-containing products within 3 months prior to the screening visit

  17. Poor intravenous access

  18. Blood pressure less than 100/50 mm Hg or greater than or equal to 160/100 mm Hg at screening visit

  19. Heart rate greater than or equal to 100 beats/min at screening visit

  20. Fasting plasma glucose <60 mg/dL or ≥126 mg/dL at screening visit

  21. Translational Research Institute (TRI) staff member or immediate relative of TRI staff member, directly involved with this study

  22. History of any illness or condition that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by study participation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Translational Research Institute for Metabolism and Diabetes Orlando Florida United States 32804

Sponsors and Collaborators

  • AdventHealth Translational Research Institute

Investigators

  • Principal Investigator: Steven R Smith, MD, Prinicipal Investigator

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
AdventHealth Translational Research Institute
ClinicalTrials.gov Identifier:
NCT02817659
Other Study ID Numbers:
  • TRIMDFH 778967
First Posted:
Jun 29, 2016
Last Update Posted:
Jan 21, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by AdventHealth Translational Research Institute
Glucagon
Additional relevant MeSH terms:
Glucagon

Study Results

No Results Posted as of Jan 21, 2022