Active — Not RecruitingPhase 1

To Determine Tolerability to Glucagon Infusion in Obese Subjects

United States20 participantsStarted 2016-11-01

Plain-language summary

To further understand the tolerability of glucagon.

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 18-55 years, inclusive
✓. BMI ≥27 to ≤40 kg/m2
✓. Stable body weight for 3 months (self-reported loss/gain \<5%)
✓. Subject is judged to be non-diabetic and in good health on the basis of medical history, physical examination, electrocardiogram, and routine laboratory data
✓. 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
✓. Subject is willing to avoid alcohol consumption for 48 hours prior to the inpatient study visit
✓. Subject is willing to avoid consumption of caffeine and caffeinated beverages for 24 hours prior to the inpatient study visit
✓. Subject is 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 (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)
✕. History of bariatric surgery
✕. Current liver, renal, pulmonary, cardiac, oncologic, metabolic, gastrointestinal or hematologic disease which the Investigator believes is clinically significant, including:
✕. 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
✕. 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
✕. 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)
✕. 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
✕. History of irritable bowel disease, recurrent nausea or vomiting

What they're measuring

Measure glucagon tolerance in healthy obese subject prior to subject becoming significantly nauseous.

Timeframe: Visit 1, measured at 30 minutes

Measure glucagon tolerance in healthy obese subject prior to subject becoming significantly nauseous.

Timeframe: Visit 1, measured at 60 minutes

Trial details

NCT IDNCT02817659

SponsorAdventHealth Translational Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01-13

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