Diabetes Mellitus Clinical Trial
Official title:
Assessment of Value of Skin Autofluorescence in Detecting Diabetes Mellitus or Impaired Glucose Tolerance. Comparison With Fasting Plasma Glucose and Glycated Hb
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.
n/a
Observational Model: Cohort, Time Perspective: Cross-Sectional
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