Secretin Increases Glucose Uptake in Human Brown Adipose Tissue and Induces Satiation.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Secretin induces satiation
研究概览
简要总结
15 healthy males will be studied with PET/CT, using FDG to investigate glucose metabolism, and radiowater to investigate perfusion. One scan will be performed in controlled cold exposure, to see whether subjects have cold activated brown adipose tissue. Two scans will be performed in room temperature conditions, where all subjects are blinded and randomised to receive placebo and secretin hydrochloride. PET/CT scans will be analysed blinded.
20 healthy males will also be studied with fMRI, in order to investigate brain activity responses to appetizing versus bland foods. This study will be conduced on the same patients as the PET/CT study, but additional subjects with same inclusion and exclusion criteria will be recruited. Two fMRI scans will be performed in room temperature conditions, where all subjects are blinded and randomised to receive placebo and secretin hydrochloride. fMRI scans will be analysed blinded.
详细描述
The PET/CT study will consist of 15 healthy, normal weight males, between ages 18-65. A 2-hour oral glucose tolerance test is performed on screening day. Calorimetry data is collected at baseline (resting and fasting) condition.
Three PET/CT scans on three different days will be performed to all 15 study subjects. Radiowater (15O)-H2O is used to study perfusion and FDG ((F18)-FDG) to study glucose metabolism. After radiowater, PET data is collected from the neck area for 6 minutes. After FDG, PET data is collected for 40 minutes on the neck area, 15 minutes on the chest, 15 minutes on the abdomen and 15 minutes on the brain. Calorimetry is collected during the entire scan. Blood samples are collected during scans for metabolites and for a plasma activity curve.
One scan is performed during controlled, cold exposure. This is done to investigate, whether patients have cold activated brown adipose tissue. After this, subjects will undergo two room temperature condition scans on different days, where participants are single-blinded and randomised to receive placebo (saline) or secretin (secretin hydrochloride) infusions. All scans are done in fasting conditions. After subjects have fed at the PET centre, calorimetry data is collected on all days.
A full body MRI will be performed on a separate day with the Dixon-method.
After scanning visits, brown adipose tissue biopsies will be taken from volunteers by a plastic surgeon. These samples are analysed in Munich.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Participants receive drug and placebo infusion without knowing which day is which.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy normal weight
排除标准
- •cardiovascular disease, diabetes
研究组 & 干预措施
Secretin study
PET and MRI scannings will be performed twice. Subjects will be given secretin hydrochloride and placebo on separate days. In addition, subjects will undergo cold exposure PET scanning once.
干预措施: Secretin Human (Drug)
Secretin study
PET and MRI scannings will be performed twice. Subjects will be given secretin hydrochloride and placebo on separate days. In addition, subjects will undergo cold exposure PET scanning once.
干预措施: Saline Solution (Drug)
Secretin study
PET and MRI scannings will be performed twice. Subjects will be given secretin hydrochloride and placebo on separate days. In addition, subjects will undergo cold exposure PET scanning once.
干预措施: Cold exposure (Other)
结局指标
主要结局
Secretin induces satiation
时间窗: Effect within one hour
Secretin attenuates brain activity, when subjects are viewing palatable vs. non-palatable food images.
Secretin activates brown fat
时间窗: Effect within six minutes
Secretin increases brown adipose tissue flow compared to placebo. This is studied with PET/CT, using a radiowater tracer.
次要结局
- Secretin reduces food consumption.(Within three days)
- Secretin increases whole body energy expenditure(Effect within two hours)
- Secretin induces satiety(Effect within three hours)
研究者
Pirjo Nuutila
Professor, MD PhD
Turku University Hospital