A Randomized Clinical Trial to Study Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Ambient plasma glucose concentration during the GGI
研究概览
简要总结
This study will test the hypotheses that a single dose of oxyntomodulin (OXM) will be neutral or better than placebo in lowering ambient glucose levels during a graded glucose infusion (GGI) and that a single dose of OXM will lead to a statistically significant increase in the sum of the plasma βOHB + AcAc levels compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is judged to be in good health based on medical history, physical examination, and laboratory safety tests
- •Subject has a Body Mass Index of ≥27 kg/m^2 and ≤35 kg/m^2 and weighs ≥70 kg at the prestudy (screening) visit
- •Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
- •Subject is willing to avoid strenuous physical activity (weight lifting, running, bicycling, etc.) for the duration of the study
排除标准
- •Subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit
- •Subject has a history of stroke, chronic seizures, or major neurological disorder
- •Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- •Subject has irritable bowel disease, or recurrent occurrences of nausea, vomiting, diarrhea, or abdominal pain
- •Subject has a history of hypertension requiring treatment
- •Subject has a history of cancer
- •Subject has history of diabetes, or family history of diabetes mellitus
- •Subject has a history of hypersensitivity to OXM or hemaccel
研究组 & 干预措施
Treatment sequence 1
OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min - Placebo
干预措施: Oxyntomodulin (OXM) (Drug)
Treatment sequence 2
OXM 0.6 pmol/kg/min - Placebo - OXM 3.0 pmol/kg/min
干预措施: Oxyntomodulin (OXM) (Drug)
Treatment sequence 3
Placebo - OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min
干预措施: Oxyntomodulin (OXM) (Drug)
Treatment sequence 4
OXM 3.0 pmol/kg/min - Placebo - OXM 0.6 pmol/kg/min
干预措施: Oxyntomodulin (OXM) (Drug)
Treatment sequence 5
Placebo - OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min
干预措施: Oxyntomodulin (OXM) (Drug)
Treatment sequence 6
OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min - Placebo
干预措施: Oxyntomodulin (OXM) (Drug)
结局指标
主要结局
Ambient plasma glucose concentration during the GGI
时间窗: Last 160 minutes of OXM/placebo infusion
plasma βOHB + AcAc concentrations
时间窗: First 300 minutes of OXM/placebo infusion
次要结局
未报告次要终点