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临床试验/NCT01406665
NCT01406665已完成不适用

Assessment of Value of Skin Autofluorescence in Detecting Diabetes Mellitus or Impaired Glucose Tolerance. Comparison With Fasting Plasma Glucose and Glycated Hb

University Medical Center Groningen2 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
218
试验地点
2
主要终点
oGTT (WHO criteria)-defined impaired glucose tolerance or diabetes

研究概览

简要总结

Early detection of (pre)diabetes, including impaired glucose tolerance is currently deficient because the best accepted standard, an oral glucose tolerance test (oGTT), is not feasible in a setting of screening or broad case-finding and other current methods lack in sensitivity. A previously reported study, and analysis of retrospective skin autofluorescence (AF) data, suggests that noninvasive skin AF may offer an alternative for detection of (pre)diabetes. The objective is to test the validity of a decision tree based on skin autofluorescence, and some simple clinical characteristics, as a detection tool for diabetes and impaired glucose tolerance. Sensitivity and specificity, positive and negative predictive value of this skin AF based decision model will be compared to those of fasting plasma glucose (FPG), glycated haemoglobin (HbA1c), and to two short questionnaires (Finnish Findrisk, and Cambridge score).

Study design: Skin AF, HbA1c and an oGTT (including an FPG) will be simultaneously performed in at least 120 persons with the characteristics described in the following paragraph. A Findrisk and Cambridge questionnaire will also be collected.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age >20 years
  • additionally a priori intermediate risk for IGT/diabetes: by having at least one criterion from the metabolic syndrome, or by at least once having had an increased glucose or glycated hemoglobin value in the preceding two years, but these outside the range of diabetes/IGT

排除标准

  • known diabetes mellitus
  • use of oral antidiabetics for other purposes than diabetes such as hepatic steatosis
  • local skin disease of the lower arm obviating skin autofluorescence measurement
  • known serious renal insufficiency (s-creatinine > 180 umol/l).
  • inability to fill in questionnaires

结局指标

主要结局

oGTT (WHO criteria)-defined impaired glucose tolerance or diabetes

时间窗: individually immediately following test, for study <26 weeks

numbers of true and false positives and negatives for oGTT (WHO criteria)-defined impaired glucose tolerance or diabetes are scored for Skin autofluorescence (based decision tree), FPG and HbA1c

次要结局

  • Findrisk diabetes questionnaire score(individually immediately after test, for study <26 weeks)

研究者

申办方类型
Other

研究点 (2)

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