跳至主要内容
临床试验/NCT03867656
NCT03867656已完成不适用

Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年2月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
CTX

研究概览

简要总结

Both GLP-2 and GIP reduce the bone resorption (measured as CTX) in healthy persons. In this study, we will investigate wether GLP-2 and GIP is reducing CTX in persons with type 2 diabetes.

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 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Age 25 to 70 years old.
  • •Type 2 diabetes.
  • •In Metformin or sulfonylureas

排除标准

  • •Treatment with other antidiabetics
  • •Osteopososis or gastrointestinal disease
  • •Long term steroid treatment
  • •Weight change more than 3 kg within the last 3 months.
  • •Overweight or intestinal surgery

研究组 & 干预措施

Placebo

Placebo Comparator

Saline

干预措施: Placebo (Other)

GLP-2

Experimental

Glucagon-like peptide 2

干预措施: GLP-2 (Other)

GIP

Experimental

Glucose-dependent insulinotropic polypeptide

干预措施: GIP (Other)

结局指标

主要结局

CTX

时间窗: -10 minutes to 240 minutes

Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum.

P1NP

时间窗: -10 minutes to 240 minutes

Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum.

次要结局

  • Glucose(-10 minutes to 240 minutes)
  • PTH(-10 minutes to 240 minutes)
  • Insulin(-10 minutes to 240 minutes)
  • GIP(-10 minutes to 240 minutes)
  • C-peptide(-10 minutes to 240 minutes)
  • GLP-2(-10 minutes to 240 minutes)
  • Glucagon(-10 minutes to 240 minutes)
  • Sclerostin(-10 min to 240 min.)
  • Blood pressure(-10 minutes to 240 minutes)
  • Heart rate(-10 minutes to 240 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kirsa Skov-Jeppesen

Principal Investigator

University of Copenhagen

研究点 (1)

Loading locations...

相似试验

Effects of Gut Peptides on Bone Remodeling.... | 临床试验