To Determine Tolerability to Glucagon Infusion in Obese Subjects (GIO)

February 5, 2024 updated by: AdventHealth Translational Research Institute

A Pilot Study to Determine Tolerability to Glucagon Infusion in Obese Subjects

To further understand the tolerability of glucagon.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Translational Research Institute for Metabolism and Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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:

    1. 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
    2. 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
    3. 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)
    4. 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
    5. History of irritable bowel disease, recurrent nausea or vomiting
    6. Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women)
  4. Self-reported history of hepatitis B, hepatitis C, or HIV
  5. 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.)
  6. Diagnosis of sleep apnea with or without use of (continuous positive airway pressure)
  7. Major surgery within last 3 months
  8. Blood donation within 4 weeks prior to the screening visit
  9. 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.
  10. Illicit drug abuse or use of nicotine-containing products within 3 months prior to the screening visit
  11. Poor intravenous access
  12. Blood pressure less than 100/50 mm Hg or greater than or equal to 160/100 mm Hg at screening visit
  13. Heart rate greater than or equal to 100 beats/min at screening visit
  14. Fasting plasma glucose <60 mg/dL or ≥126 mg/dL at screening visit
  15. Translational Research Institute (TRI) staff member or immediate relative of TRI staff member, directly involved with this study
  16. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure glucagon tolerance in healthy obese subject prior to subject becoming significantly nauseous.
Time Frame: 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.
Visit 1, measured at 30 minutes
Measure glucagon tolerance in healthy obese subject prior to subject becoming significantly nauseous.
Time Frame: 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.
Visit 1, measured at 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

January 13, 2017

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (Estimated)

June 29, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIMDFH 778967

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Glucagon

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe