Postprandial Regulation of Bone Perfusion in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Median Ki in the Femur
研究概览
简要总结
The goal of this clinical trial is to learn whether certain natural hormones - Glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-2, (GLP-2), and amylin - affect blood flow to the bones.
详细描述
In this study, participants will attend four study visits. At each visit they will be given infusions with either one of these hormones (GIP, GLP-2, pramlintide (a drug that mimics the natural hormone amylin)) or a placebo infusion (salt water). At the same time, participants will undergo a PET/CT scan where they will be administered a bone tracer (sodium fluoride), to visualize bone blood flow and activity. Participants do not know whether they are given active hormone or placebo infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 25-50 years.
- •BMI between 18.5-30 kg/m
- •Normal gait.
- •Premenopausal (if female).
- •Informed consent.
排除标准
- •Bone disease incl. confirmed osteopenia.
- •Fracture within the last 6 months at the time of inclusion.
- •Amputation or congenital defect of extremities.
- •HbA1c>41.9 mmol/mol and/or diagnosed type 1 or type 2 diabetes.
- •Any ongoing or prior medication that the investigator evaluates could interfere with the endpoints of the study (e.g. glucocorticoids or other medications that may compromise bone health).
- •Pregnancy or breastfeeding (or plans thereof within the study duration).
- •Not using effective hormonal contraceptives or an intra uterine device within study duration (e.g. oral contraceptives, transdermal patch, vaginal ring, Depo-Provera injections, Nexplanon implant).
- •Ongoing or prior alcohol abuse (defined per ICD-10 classification for alcohol dependence syndrome, F10.21) or daily alcohol intake
- •Use of any illicit substance or narcotics within three months of inclusion, including within study duration.
- •Any physical or psychological condition that the investigator evaluates would interfere with trial participation.
- •Recent (three months prior to inclusion), ongoing or planned weight loss within study duration (weight loss defined as exceeding -5% bodyweight, or intentional hypocaloric dieting)
研究组 & 干预措施
Isotonic saline
Saltwater infusion in a peripheral vein
干预措施: isotonic saline infusion (Other)
GIP(1-42)
Infusion of the native hormone GIP(1-42) in a peripheral vein
干预措施: Infusion of GIP(1-42) (Other)
GLP-2(1-33)
Infusion of the native hormone GLP-2(1-33) in a peripheral vein
干预措施: Infusion of GLP-2(1-33) (Other)
Pramlintide
Infusion of pramlintide (amylin analogue) in a peripheral vein
干预措施: Infusion of pramlintide (Other)
结局指标
主要结局
Median Ki in the Femur
时间窗: 90 minutes
Kinetic modelling
次要结局
- Mean difference in P1NP(90 minutes)
- Bone incorporation fraction (K3/K3+K2)(90 minutes.)
- Median Ki in the lumbar spine(90 minutes)
- Ki in other bones.(90 minutes)
- Bone perfusion (K1)(90 minutes)
- Mean difference in PTH.(90 minutes.)
- Mean difference in GIP(1-42)(90 minutes.)
- Mean difference in GLP-2(1-33)(90 minutes.)
- Mean difference in pramlintide(90 minutes.)
- Mean difference in blood glucose(90 minutes.)
- Mean difference in C-peptide(90 minutes.)
- Mean difference in CTX(90 minutes.)