Skin Autofluorescence (AF) Decision Tree in Detecting Impaired Glucose Tolerance (IGT) or Diabetes Mellitus (DM)

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Impaired Glucose Tolerance

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -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 Exclusion Criteria:-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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| increased diabetes risk<br>the recruited group consists of persons with moderate to high risk for impaired glucose tolerance or diabetes | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oGTT (WHO criteria)-defined impaired glucose tolerance or diabetes | 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 | individually immediately following test, for study <26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Findrisk diabetes questionnaire score | Findrisk diabetes questionnaire score is based on anthropometric data and questionnaire. | individually immediately after test, for study <26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, impaired glucose tolerance