Effect of Prolonged (72 Hour) Glucagon Administration on Energy Expenditure in Healthy Obese Subjects (GIO B)

February 5, 2024 updated by: AdventHealth Translational Research Institute
The main purpose of this study is to examine the effect of prolonged (72 hour) administration of glucagon compared to placebo on energy expenditure in healthy, non-diabetic, obese subjects.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

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:

  • Age 18-55 years, inclusive.
  • Body Mass Index (BMI) ≥27 to ≤45 kg/m2 and body weight <450 lbs.
  • Stable body weight for 3 months (self-reported loss/gain <5%).

  • Judged to be non-diabetic per the American Diabetes Association guidelines:

    1. fasting plasma glucose <126 mg/dL [7.0 mmol/L] and
    2. HbA1c <6.5% [48 mmol/mol]) and
    3. in good health on the basis of medical history, physical examination (PE), electrocardiogram (ECG), and normal laboratory values obtained from Screening visit labs.
  • 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.
  • Willing to avoid alcohol consumption for 48 hours prior to the inpatient study visit.
  • Willing to avoid consumption of caffeine and caffeinated beverages for 24 hours prior to the inpatient study visit.
  • Willing to avoid strenuous physical activity for 72 hours prior to the inpatient study visit.

Exclusion Criteria

  • Treatment with any medication known to significantly impact body weight or energy metabolism (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).
  • Treatment with a selective serotonin reuptake inhibitor, a medication for depression or apomorphine within one week prior to screening due to interaction with Zofran.
  • History of bariatric surgery.

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

    a. 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.

  • Impaired renal function as indicated by an estimated glomerular filtration rate (eGFR) <60 mL/min or urine albumin-to-creatinine ratio >35 mg/mmol.
  • 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 [MI], transient ischemic attack, cerebrovascular accident [CVA], angina, and hospitalization due to CHF,transient ischemic attack, and CVA).
  • Metabolic, or other 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 >ULN <10 U/mL and symptomatic or TSH >10 U/mL), Cushing's disease/syndrome, Addison's disease, hypogonadism, or genetic disorders linked to obesity.
  • History of irritable bowel disease, recurrent nausea, or vomiting.
  • Anemia (hemoglobin <12 g/dL in males, <11 g/dL in females).
  • History of dyslipidemia: Fasting triglycerides (TG) >500 mg/dL and low-density lipoproteins (LDL) >250 mg/dL.
  • Self-reported history of infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
  • 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.).
  • Diagnosis of sleep apnea with or without use of continuous positive airway pressure/BiPAP/AutoPAP.
  • Major surgery within 3 months prior to screening.
  • Blood donation within 4 weeks prior to screening.
  • Participation in another investigational trial within 4 weeks prior to screening. 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 screening of the current trial.
  • Use of illicit drugs or nicotine-containing products within 3 months prior to screening.
  • Poor intravenous (IV) access.
  • Blood pressure <100/50 mmHg or ≥160/100 mmHg during screening.
  • Heart rate ≥100 bpm during screening.
  • Fasting plasma glucose <60 mg/dL or ≥126 mg/dL during screening.
  • Female subjects who are, or intend to become, pregnant during the course of this study, are currently breastfeeding, or women of child-bearing potential (WOCBP) who refuse to use at least one method of birth control (oral contraceptives, intrauterine device, implanted or injectable contraceptives, abstinence).
  • Translational Research Institute for Metabolism and Diabetes (TRI-MD) staff member or immediate relative of TRI-MD staff members directly involved
  • 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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Intravenous infusion of saline for 72 hours
Active Comparator: Glucagon Low Dose
Drug: Glucagon
Low dose intravenous infusion for 72 hours at 12.5 ng/kg/min
Drug: Glucagon
High dose intravenous infusion for 72 hours at 25 ng/kg/min
Active Comparator: Glucagon High Dose
Drug: Glucagon
Low dose intravenous infusion for 72 hours at 12.5 ng/kg/min
Drug: Glucagon
High dose intravenous infusion for 72 hours at 25 ng/kg/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy Expenditure
Time Frame: 24 hours
24 hours
Effects of continuous IV infusion of glucagon versus placebo
Time Frame: 72 hours
Overall well-being will be measured by administering a questionnaire with a scale from none to severe.
72 hours

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 Smith, MD, Study Principal 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)

October 24, 2017

Primary Completion (Actual)

February 14, 2018

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Estimated)

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 954476

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

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.

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