NCT02237053已完成1 期
A Prospective Randomized, Placebo (Saline)-Controlled, Balanced, 3-treatment Regimen Crossover Study Comparing the Effects of Prolonged (13 h) Hyperglucagonemia With Those of Acute (3 hr) Hyperglucagonemia on Energy Expenditure and Endogenous Glucose Protection (EGP).
AdventHealth Translational Research Institute1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Measure of energy expenditure
研究概览
简要总结
The purpose of this study is to collect data to help researchers better understand the effects of glucagon on the amount of calories burned.
详细描述
- To compare the effect of prolonged hyperglucagonemia to that of acute hyperglucagonemia on energy expenditure in healthy subjects using room indirect calorimetry in the setting of octreotide-mediated prevention of plasma insulin excursions.
- To compare the effects of prolonged hyperglucagonemia to acute hyperglucagonemia on EGP in healthy subjects in the setting of octreotide-mediated prevention of plasma insulin excursions.
- To determine the effects of prolonged hyperglucagonemia to acute hyperglucagonemia on rates of substrate oxidation, fibroblast growth factor21 and metabolites of interest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is a male between the ages of 18 and 50 years.
- •Subject has a body mass index (BMI) less than or equal to 26 kg/m
- •BMI = weight (kg)/height (m) and body weight greater than or equal to 50 kg at the pre-study (screening) visit
- •Subject has been weight stable over the last 3 months (plus or minus 3 kg)
- •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 each period.
- •Subject is willing to avoid strenuous physical activity (i.e., strenuous or unaccustomed weight lifting, running, bicycling, etc.) beginning 72 hours prior to first drug administration period and for the duration of the study.
- •Subject is willing to avoid consumption of caffeine and caffeinated beverages for 24 hours prior to drug administration in each period. Subject is willing to consume no more than 2 caffeinated beverages per day during all other parts of the study.
排除标准
- •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.
研究组 & 干预措施
Glucagon with Octreotide and insulin
Active Comparator
Overnight (10 hours) infusion of glucagon, then 3 hours infusion of glucagon with concurrent infusions of Octreotide and insulin.
干预措施: Glucagon (Drug)
Glucagon with Octreotide and insulin
Active Comparator
Overnight (10 hours) infusion of glucagon, then 3 hours infusion of glucagon with concurrent infusions of Octreotide and insulin.
干预措施: Octreotide (Drug)
Glucagon with Octreotide and insulin
Active Comparator
Overnight (10 hours) infusion of glucagon, then 3 hours infusion of glucagon with concurrent infusions of Octreotide and insulin.
干预措施: Insulin (Drug)
Placebo, Glucagon with Octreotide and Insulin
Placebo Comparator
Overnight (10 hours) infusion of saline, then 3 hour infusion of glucagon with concurrent infusions of Octreotide and insulin.
干预措施: Glucagon (Drug)
Placebo, Glucagon with Octreotide and Insulin
Placebo Comparator
Overnight (10 hours) infusion of saline, then 3 hour infusion of glucagon with concurrent infusions of Octreotide and insulin.
干预措施: Octreotide (Drug)
Placebo, Glucagon with Octreotide and Insulin
Placebo Comparator
Overnight (10 hours) infusion of saline, then 3 hour infusion of glucagon with concurrent infusions of Octreotide and insulin.
干预措施: Placebo (Behavioral)
Placebo, Glucagon with Octreotide and Insulin
Placebo Comparator
Overnight (10 hours) infusion of saline, then 3 hour infusion of glucagon with concurrent infusions of Octreotide and insulin.
干预措施: Insulin (Drug)
Placebo, with Octreotide and insulin
Placebo Comparator
Overnight (10 hours) infusion of saline, then 3 hour infusion of saline with concurrent infusions of Octreotide and insulin.
干预措施: Octreotide (Drug)
Placebo, with Octreotide and insulin
Placebo Comparator
Overnight (10 hours) infusion of saline, then 3 hour infusion of saline with concurrent infusions of Octreotide and insulin.
干预措施: Placebo (Behavioral)
Placebo, with Octreotide and insulin
Placebo Comparator
Overnight (10 hours) infusion of saline, then 3 hour infusion of saline with concurrent infusions of Octreotide and insulin.
干预措施: Insulin (Drug)
结局指标
主要结局
Measure of energy expenditure
时间窗: Day 2, Day 9, Day 16
Energy expenditure (and respiratory quotient) will be measured within the small calorimeter rooms. Oxygen and carbon dioxide levels in the chambers will be measured.
次要结局
- Measure of endogenous glucose production(Day 3, Day 10, Day 17)
研究者
研究点 (1)
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