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临床试验/NCT03325569
NCT03325569已完成不适用

Reduced GLP-1 Response is Associated With Prediabetes in Women With Adverse Metabolic Phenotype of PCOS Independently of BMI

University Medical Centre Ljubljana2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2017年2月13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
26
试验地点
2
主要终点
The main outcome was difference in fasting and after load GLP1 levels between two groups

研究概览

简要总结

Women with PCOS are more prone to obesity which exacerbates insulin resistance, the abdominal fat disposition and metabolic risk of these patients. With development of obesity these women have high conversion rate from normal glucose tolerance to impaired glucose tolerance and in turn to type 2 diabetes.

Glucagon-like peptide 1 (GLP-1) is involved in body weight maintenance. Beside energy balance it is also involved in glucose homeostasis. Functional deficit in GLP-1 facilitates obesity. We investigated the link between the concentration of incretin hormones and glucose homeostasis, metabolic complications and the distribution of body composition in obese women with PCOS.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 years old to menopause
  • polycystic ovary sindrome (NICHD criteria)
  • BMI of 30 kg/m2 or higher

排除标准

  • type 1 or type 2 diabetes mellitus
  • Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
  • personal or family history of MEN 2
  • the use of medications known or suspected to affect reproductive or metabolic functions
  • the use of statins within 90 days prior to study entery

研究组 & 干预措施

NGT

Active Comparator

NGT - normal glucose tolerance. Women with PCOS and normal glucose tolerance

干预措施: oral glucose tolerance test (Diagnostic Test)

IGH

Active Comparator

IGH - impaired glucose homeostasis Women with PCOS and impaired glucose homeostasis - that means impaired fasting glucose or impaired glucose tolerance.

干预措施: oral glucose tolerance test (Diagnostic Test)

结局指标

主要结局

The main outcome was difference in fasting and after load GLP1 levels between two groups

时间窗: 3h

Patient GLP1 levels were measured at base point and in 120 min of 75-g OGTT. GLP1 levels were compared between groups

次要结局

  • The secondary outcome was to evaluate the between group difference in beta cell function, and visceral adipose tissue.(3h)

研究者

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

Andrej Janez

MD PhD

University Medical Centre Ljubljana

研究点 (2)

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