Total-body Glucose Utilization in Obesity
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Insulin-induced change in tissue blood flow
研究概览
简要总结
There are three goals for this study. One is to investigate how different emotions and exposure to cold affect blood flow in the body. The second aim is to study how insulin affects blood flow and tissue glucose uptake, and to study whether this effect is altered in obesity. Last, the study focuses on establishing the lowest dose of a PET radiotracer, oxygen-15 labelled water, that can be used in clinical studies with a new whole-body PET scanner.
详细描述
The study consists of two separate parts: the dose escalation study and the part studying the effects of emotions and insulin on blood flow.
All participants will first undergo a screening visit starting with signing an informed consent form. Then they will undergo a physical examination, are interviewed about their medical history. Finally, some routine laboratory tests are collected, and a 75 g oral glucose tolerance test is performed. The participants who are eligibile for the study will continue to the PET studies.
The dose escalation study will be completed first. In this 8 participants will be studied once with Siemens Biovision Quadra PET/CT scanner. They will receive eight doses of oxygen-15 labelledradiowater (H2[15O]O) ranging from 25 to 700 MBq, with each dose repeated twice to evaluate repeatability of each dose. These participants will not undergo any further studies.
For the other subjects, there will be two more PET study visits.
On the first visit, the effects of emotions, evoked by short movie clips or cold exposure of one leg, on whole-body blood flow will studied with oxygen-15 labelled radiowater. Each participant will be studied 8 times in one session, with repeated H2[15O]O boluses of 400 MBq followed by 7.5 min dynamic PET scans with Siemens Biovision Quadra PET/CT scanner and a 5 min recovery and wash-out period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20-60 years
- •BMI either 18.5-25 kg/m2 or above 30 kg/m2
- •Use of hormonal contraception for women in child bearing age
排除标准
- •In the lean group history of obesity or type 2 diabetes
- •In the group with obesity: current or previous use of GLP-1-agonists or insulin
- •History of eating disorders
- •Smoking, use of narcotics, excessive use of alcohol
- •Previous participation in PET studies
- •Previous significant exposure to radiation
- •Claustrophobia
- •Active plans for concieving (both sexes)
- •Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
研究组 & 干预措施
TOTAL dose test
The aim of the studies performed in this arm (8 subjects) is to test the lowest dose of H2[15O]O (radiowater) for the Siemens Quadra PET/CT scanner. Each participant will be studied once with the scanner with 4 different doses (25-700 MBq) of H2[15O]O, each repeated 2 times
干预措施: H2[15O]O PET/CT (Radiation)
TOTAL
The participants in this arm will undergo two PET visits. On one visit the effects of visual stimuli or cold on whole body perfusion will be studied with H2[15O]O PET/CT. On the second visit whole-body insulin sensitivity is studied with [18F]fluorodeoxyglucose PET/CT, and the acute and delayed effects of intravenous insulin on blood flow will be studied with H2[15O]O PET/CT.
干预措施: Movies (Behavioral)
TOTAL
The participants in this arm will undergo two PET visits. On one visit the effects of visual stimuli or cold on whole body perfusion will be studied with H2[15O]O PET/CT. On the second visit whole-body insulin sensitivity is studied with [18F]fluorodeoxyglucose PET/CT, and the acute and delayed effects of intravenous insulin on blood flow will be studied with H2[15O]O PET/CT.
干预措施: Cold (Behavioral)
TOTAL
The participants in this arm will undergo two PET visits. On one visit the effects of visual stimuli or cold on whole body perfusion will be studied with H2[15O]O PET/CT. On the second visit whole-body insulin sensitivity is studied with [18F]fluorodeoxyglucose PET/CT, and the acute and delayed effects of intravenous insulin on blood flow will be studied with H2[15O]O PET/CT.
干预措施: Hyperinsulinemic euglycemic clamp (Drug)
TOTAL
The participants in this arm will undergo two PET visits. On one visit the effects of visual stimuli or cold on whole body perfusion will be studied with H2[15O]O PET/CT. On the second visit whole-body insulin sensitivity is studied with [18F]fluorodeoxyglucose PET/CT, and the acute and delayed effects of intravenous insulin on blood flow will be studied with H2[15O]O PET/CT.
干预措施: H2[15O]O PET/CT (Radiation)
TOTAL
The participants in this arm will undergo two PET visits. On one visit the effects of visual stimuli or cold on whole body perfusion will be studied with H2[15O]O PET/CT. On the second visit whole-body insulin sensitivity is studied with [18F]fluorodeoxyglucose PET/CT, and the acute and delayed effects of intravenous insulin on blood flow will be studied with H2[15O]O PET/CT.
干预措施: [18F]FDG PET/CT (Radiation)
TOTAL
The participants in this arm will undergo two PET visits. On one visit the effects of visual stimuli or cold on whole body perfusion will be studied with H2[15O]O PET/CT. On the second visit whole-body insulin sensitivity is studied with [18F]fluorodeoxyglucose PET/CT, and the acute and delayed effects of intravenous insulin on blood flow will be studied with H2[15O]O PET/CT.
干预措施: CEUS or Contrast enhanced Ultrasound (Drug)
结局指标
主要结局
Insulin-induced change in tissue blood flow
时间窗: Change from fasting condition to 10 minutes and 50 minutes after the start of insulin infusion
Brain, liver, skeletal muscle and brain blood-flow (ml/100 g/min) measured with H2\[15O\]O PET/CT
次要结局
- Effects of insulin on skeletal muscle microvascular perfusion(Change from fasting condition to 10 minutes and 50 minutes after the start of insulin infusion)
- Tissue insulin-stimulated glucose uptake(Measured from 60 to 110 minutes after the start of insulin infusion)
- Effects of emotions on whole-body blood flow(Measured during 60-second activation blocks (visual stimuli) or during 5 min cold-exposure)
- Range of effective and feasible radiowater doses with whole-body PET/CT(During repetitive H2[15O]O scans (a total of 120 minutes))
研究者
Pirjo Nuutila
professor
Turku University Hospital