2024-510885-17-01招募中1 期
Defining the Glucagon Unit: Investigating the Impact on Energy Expenditure and Glucose Level Deviation in healthy volunteers
Pauls Stradins Clinical University Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年6月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change from baseline in resting energy expenditure (EE) measured by indirect calorimetry after intervention with glucose, intravenous glucose, intravenous glucagon, semaglutide, saline, and additional glucagon infusion.
研究概览
简要总结
The primary objective of this study is to define the glucagon unit by investigating its impact on energy expenditure, glucose level deviation in the presence and absence of incretin-stimulated insulin secretion, and comparing the results with intravenous (i/v) and oral (p/o) glucose uptake.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 40 years.
- •BMI 25 - 34.
- •Signed informed consent
排除标准
- •Not signed informed consent
- •Abnormal laboratory results: ○ TSH < 0,4 or > 4,0 mIU/L ○ ALAT > 40 U/L ○ CKD (GFR < 90 ml/min/m2) ○ Abnormal fasting glucose (≥6.1 mmol/L) ○ abnormal HbA1c (≥5.7%) ○ Other significant deviations according to research team views
- •Diabetes mellitus (any type).
- •Current use of any anti-diabetic drugs (for any indication).
- •Any other medical condition or treatment that, in the opinion of the investigator, would interfere with the study objectives, conduct, or interpretation of results.
- •Inability to tolerate calorimeter canopy.
- •Participants who have received any investigational product or medication within 180 days prior to screening.
- •Participants who have donated blood or plasma within 30 days prior to screening.
- •Participants who have a known allergy or intolerance to any of the study medications or their components.
- •Inability to comply with study requirements
- •BMI > 35 kg/m2 and < 25 kg/m2
- •History of gastrointestinal disorders, surgery or other medical conditions that could affect nutrient absorption and/or predispose a subject to side effects of GLP-RA (chronic pancreatitis, dysmotility, rapidly growing thyroid nodules etc)
结局指标
主要结局
Change from baseline in resting energy expenditure (EE) measured by indirect calorimetry after intervention with glucose, intravenous glucose, intravenous glucagon, semaglutide, saline, and additional glucagon infusion.
Change from baseline in resting energy expenditure (EE) measured by indirect calorimetry after intervention with glucose, intravenous glucose, intravenous glucagon, semaglutide, saline, and additional glucagon infusion.
次要结局
- Change from baseline in respiratory quotient (RQ) measured by indirect calorimetry after intervention with glucose, intravenous glucose, intravenous glucagon, semaglutide, saline, and additional glucagon infusion.
- Change from baseline in carbohydrate oxidation rates measured by indirect calorimetry after intervention with glucose, intravenous glucose, intravenous glucagon, semaglutide, saline, and additional glucagon infusion.
- Change from baseline in fat oxidation rates measured by indirect calorimetry after intervention with glucose, intravenous glucose, intravenous glucagon, semaglutide, saline, and additional glucagon infusion.
- Changes in blood levels of insulin, glucose, GLP-1, and glucagon at predetermined intervals after intervention with glucose, intravenous glucose, intravenous glucagon, semaglutide, saline, and additional glucagon infusion.
- Side effects reported during the self-observation weeks after each intervention.
- Body weight changes throughout the study period, including before and after each intervention.
- Comparison of postprandial glucose excursion between different interventions, measured by continuous glucose monitoring (CGM).
- Assessment of changes in urinary nitrogen excretion as a measure of protein metabolism in response to interventions.
研究者
Svjatoslavs Kistkins
Scientific
Pauls Stradins Clinical University Hospital
研究点 (1)
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