Skin Autofluorescence (AF) Decision Tree in Detecting Impaired Glucose Tolerance (IGT) or Diabetes Mellitus (DM)
|ClinicalTrials.gov Identifier: NCT01406665|
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : August 1, 2011
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.
|Condition or disease|
|Diabetes Mellitus Impaired Glucose Tolerance|
|Study Type :||Observational|
|Actual Enrollment :||218 participants|
|Official Title:||Assessment of Value of Skin Autofluorescence in Detecting Diabetes Mellitus or Impaired Glucose Tolerance. Comparison With Fasting Plasma Glucose and Glycated Hb|
|Study Start Date :||October 2010|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
increased diabetes risk
the recruited group consists of persons with moderate to high risk for impaired glucose tolerance or diabetes
- oGTT (WHO criteria)-defined impaired glucose tolerance or diabetes [ Time Frame: 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
- Findrisk diabetes questionnaire score [ Time Frame: individually immediately after test, for study <26 weeks ]Findrisk diabetes questionnaire score is based on anthropometric data and questionnaire.
Biospecimen Retention: None Retained
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406665
|Apeldoorn, Gelderland, Netherlands, 7334 DZ|
|University Medical Center Groningen|
|Groningen, Netherlands, 9700 RB|