Quantitative PET Imaging of Pancreatic Beta-Cell Mass in Healthy Overweight/Obese Subjects, Subjects With Prediabetes, and Type 2 Diabetes Patients With 18F-FP-DTBZ (18F-AV-133)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133
研究概览
简要总结
To evaluate 18F-AV-133 imaging of the pancreas in patients with early type 2 diabetes, late type 2 diabetes, subjects with pre-diabetes and in healthy overweight/obese control subjects. These subjects will also be evaluated for beta-cell function as measured by the insulin and C-peptide response to a challenge with intravenous arginine under basal and glucose enhanced conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and/or female subjects of non-childbearing potential between the ages of 30 and 65 years inclusive.
- •Able to tolerate PET, PET/CT and MR imaging
- •Estimated creatinine clearance >= 60mL/min
- •Informed consent documents signed and dated by subject
- •Subjects must be willing and able to comply with all scheduled visits, treatments laboratory tests, scans and other study procedures.
- •In addition, subjects must meet classification requirements for one of the following
- •Healthy Overweight
- •Pre-diabetes
- •(T2DM only) Subjects with other chronic medical conditions (besides diabetes) that are well controlled and stable on medication are acceptable for inclusion in this study.
排除标准
- •Subjects who are affiliated with or relatives of staff members of either the site or Pfizer directly involved in the conduct of the trial.
- •Conditions which in the opinion of the study investigator may interfere with the subject's ability to participate in the study
- •History of allergic reaction to drug/contrast agent or history of drug/alcohol abuse
- •Subjects who have received investigational medications within the last 30 days or a radiopharmaceutical in the past 7 days.
- •Pregnant or nursing females; females of childbearing potential.
研究组 & 干预措施
Arginine Stimulation Testing
Establish the methodology for glucose enhanced arginine stimulation testing (AST).
干预措施: 10% Arginine Hydrochloride-R-Gene 10 (Drug)
PET Imaging
Determine if pancreatic PET-determined binding measures of 18F-AV-133 differ in up to 60 subjects determined to be at one of four stages of the natural history of Type 2 Diabetes: Healthy Overweight/obese Volunteers (HOV), Subjects with Pre-diabetes (PD) and Type 2 Diabetes mellitus (T2DM).
干预措施: 18F-AV-133 (Drug)
PET Imaging
Determine if pancreatic PET-determined binding measures of 18F-AV-133 differ in up to 60 subjects determined to be at one of four stages of the natural history of Type 2 Diabetes: Healthy Overweight/obese Volunteers (HOV), Subjects with Pre-diabetes (PD) and Type 2 Diabetes mellitus (T2DM).
干预措施: 10% Arginine Hydrochloride-R-Gene 10 (Drug)
结局指标
主要结局
Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133
时间窗: PET visit 1
Optimal PET-determined mean pancreatic Binding Potential of 18F-AV-133
时间窗: PET visit 1
Optimal PET-determined mean pancreatic Standardized Uptake Value (SUV) of 18F-AV-133
时间窗: PET visit 1
次要结局
未报告次要终点