Quantification of Amino Acid and Glucose Metabolism in Healthy Controls and Patients With Non-alcoholic Fatty Liver Disease Using Total- Body PET
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Whole-body tracer uptake (SUVmean) assessed using total-body PET/CT
研究概览
简要总结
This observational study aims to quantify whole-body amino acid and glucose metabolism in healthy adults and in patients with non-alcoholic fatty liver disease (NAFLD) using total-body PET/CT. The study investigates how orally and intravenously administered PET tracers (18F-FDG and 18F-FET) are absorbed in the gastrointestinal tract, distributed across major organs, and metabolized in different physiological and pathological states. A further objective is to examine how glucagon, during a pancreatic clamp using somatostatin, influences amino acid metabolism in healthy individuals and whether this response is altered in patients with NAFLD.
Participants will be healthy volunteers or patients with NAFLD, aged 18-70 years. Depending on study group, participants will undergo one or more total-body PET/CT scans following oral or intravenous tracer administration, and in some cases receive glucagon or placebo infusion. Blood samples will be collected during scanning to assess hormone levels and metabolic responses. Data from these imaging sessions will be used to characterize nutrient metabolism, compare oral and intravenous tracer kinetics, and explore glucagon-induced metabolic changes across study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Body mass index (BMI) 20-27 kg/m2
排除标准
- •Pregnancy
- •Claustrophobia
- •Inability to give consent due to psychological or other causes
- •Inability to speak/read Danish
- •Diabetes, cancer (active or treated within the last five years) or inflammatory diseases.
- •Low albumin
- •Chronic disorders that require medical treatment
研究组 & 干预措施
Healthy Controls: FDG (oral & IV)
Healthy volunteers receive 18F-FDG by oral administration and intravenous administration on separate study days, including an oral glucose tolerance test visit. Total-body PET/CT imaging is performed after each tracer administration.
干预措施: 18F-FDG (oral) (Drug)
Healthy Controls: FDG (oral & IV)
Healthy volunteers receive 18F-FDG by oral administration and intravenous administration on separate study days, including an oral glucose tolerance test visit. Total-body PET/CT imaging is performed after each tracer administration.
干预措施: 18F-FDG (intravenous) (Drug)
Healthy Controls: FDG (oral & IV)
Healthy volunteers receive 18F-FDG by oral administration and intravenous administration on separate study days, including an oral glucose tolerance test visit. Total-body PET/CT imaging is performed after each tracer administration.
干预措施: Oral Glucose Tolerance Test (Other)
Healthy Controls: FET (oral & IV)
Healthy volunteers receive 18F-FET by oral administration and intravenous administration on separate study days. Dynamic and static total-body PET/CT imaging is performed.
干预措施: 18F-FET (oral) (Drug)
Healthy Controls: FET (oral & IV)
Healthy volunteers receive 18F-FET by oral administration and intravenous administration on separate study days. Dynamic and static total-body PET/CT imaging is performed.
干预措施: 18F-FET (intravenous) (Drug)
Healthy Controls: Oral FET + Glucagon/Somatostatin Clamp (Crossover)
Healthy participants undergo two study days with oral ^18F-FET administration combined with either glucagon infusion during a pancreatic clamp (somatostatin infusion) or placebo. Total-body PET/CT imaging is performed using a crossover design.
干预措施: 18F-FET (oral) (Drug)
Healthy Controls: Oral FET + Glucagon/Somatostatin Clamp (Crossover)
Healthy participants undergo two study days with oral ^18F-FET administration combined with either glucagon infusion during a pancreatic clamp (somatostatin infusion) or placebo. Total-body PET/CT imaging is performed using a crossover design.
干预措施: Glucagon (Drug)
Healthy Controls: Oral FET + Glucagon/Somatostatin Clamp (Crossover)
Healthy participants undergo two study days with oral ^18F-FET administration combined with either glucagon infusion during a pancreatic clamp (somatostatin infusion) or placebo. Total-body PET/CT imaging is performed using a crossover design.
干预措施: Somatostatin (Drug)
Healthy Controls: Oral FET + Glucagon/Somatostatin Clamp (Crossover)
Healthy participants undergo two study days with oral ^18F-FET administration combined with either glucagon infusion during a pancreatic clamp (somatostatin infusion) or placebo. Total-body PET/CT imaging is performed using a crossover design.
干预措施: Sodium chloride (placebo) (Drug)
NAFLD Patients: Oral FET + Glucagon/Somatostatin Clamp (Crossover)
Participants with NAFLD undergo two study days with oral ^18F-FET administration combined with either glucagon infusion during a pancreatic clamp (somatostatin infusion) or placebo. Total-body PET/CT imaging is performed using a crossover design.
干预措施: 18F-FET (oral) (Drug)
NAFLD Patients: Oral FET + Glucagon/Somatostatin Clamp (Crossover)
Participants with NAFLD undergo two study days with oral ^18F-FET administration combined with either glucagon infusion during a pancreatic clamp (somatostatin infusion) or placebo. Total-body PET/CT imaging is performed using a crossover design.
干预措施: Glucagon (Drug)
NAFLD Patients: Oral FET + Glucagon/Somatostatin Clamp (Crossover)
Participants with NAFLD undergo two study days with oral ^18F-FET administration combined with either glucagon infusion during a pancreatic clamp (somatostatin infusion) or placebo. Total-body PET/CT imaging is performed using a crossover design.
干预措施: Somatostatin (Drug)
NAFLD Patients: Oral FET + Glucagon/Somatostatin Clamp (Crossover)
Participants with NAFLD undergo two study days with oral ^18F-FET administration combined with either glucagon infusion during a pancreatic clamp (somatostatin infusion) or placebo. Total-body PET/CT imaging is performed using a crossover design.
干预措施: Sodium chloride (placebo) (Drug)
结局指标
主要结局
Whole-body tracer uptake (SUVmean) assessed using total-body PET/CT
时间窗: 0-180 minutes after tracer administration
次要结局
未报告次要终点
研究者
Per Cramon
Physician
Rigshospitalet, Denmark