Status and phase
Conditions
Treatments
About
The purpose of this study is to collect data to help researchers better understand the effects of glucagon on the amount of calories burned.
Full description
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
is mentally or legally incapacitated, has significant emotional problems at the time of pretrial (screening) visit or expected during the conduct of the trial or has a history of clinically significant psychiatric disorder of the last 5 years. Subjects who have had situational depression may be enrolled in the trial at the discretion of the investigator.
has a history of clinically significant endocrine (including type 1 or type 2, or steroid-induced diabetes), gastrointestinal (including prior history of pancreatitis), cardiovascular (including hypertension, angina, coronary artery disease, valvular disease, heart rate or rhythm abnormalities), hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases. Subjects with a history of uncomplicated kidney stones or childhood asthma may be enrolled in the trial at the discretion of the investigator.
has a known history of any endocrine tumors (e.g. pheochromocytoma, glucagonoma, or insulinoma, etc.)
has a clinically significant abnormality on screening ECG or evidence or a history of myocardial ischemia, atrioventricular block, Wolf-Parkinson-White syndrome or other conduction abnormality. Subjects having any clinically significant ECG abnormality at screening may be included at the discretion of the PI.
has a fasting blood glucose (FPG) less than or equal to 65 mg/dL or greater than or equal to 100 mg/dL on the pre-study screening labs.
has impaired kidney or liver function, as evidenced by screening blood work.
has irritable bowel disease, or recurrent occurrences of nausea, vomiting, diarrhea, constipation or abdominal pain.
has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
has an estimated creatinine clearance of ≤80 mL/min based on the Cockcroft-Gault equation
has a history of neoplastic disease
has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food; or allergy/intolerability to insulin, glucagon, or octreotide.
is positive for hepatitis B surface antigen, hepatitis C antibodies, or HIV
had major surgery within 3 months, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial (screening) visit.
has participated in another investigational trial within 4 weeks prior to the pretrial (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 related to trial drug to the pretrial/screening visit of the current trial.
consumes greater than 2 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce]) per day. Patients that consume 4 glasses of alcoholic beverages per day may be enrolled at the discretion of the investigator.
consumes excessive amounts, defined as greater than 4 servings
(1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy-drinks, or other caffeinated beverages per day.
is currently a regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months of the screening visit.
is unwilling or unable to adhere to the dietary needs during the study, or to consume the standardized meals during the study, and/or is on a carbohydrate restricted diet (i.e., a diet <100 grams per day of carbohydrate).
is any concern by the investigator regarding the safe participation of the subject in the trial or for any other reason; the investigator considers the subject inappropriate for participation in the trial.
has a history of claustrophobia or is claustrophobic.
has ever had an organ transplant.
is a smoker or uses other nicotine-containing products (for at least 6 months prior to drug administration); plans to begin smoking or using nicotine-containing products during the conduct of the study.
has poor intravenous access.
has used any medications that are known to influence glucose, fat, or energy metabolism within the last 3 months (growth hormones, steroids, etc.)
has blood pressure at screening visit less than or equal to 100/50 mm Hg or greater than or equal to 160/100 mm Hg.
Primary purpose
Allocation
Interventional model
Masking
6 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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