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| ID | Type | Description | Link |
|---|---|---|---|
| METc 2009-367 | Other Identifier | Institutional Review Board (IRB) UMCG |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| increased diabetes risk | the recruited group consists of persons with moderate to high risk for impaired glucose tolerance or diabetes |
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| 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 |
| 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 |
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Inclusion Criteria: -age >20 years
Exclusion Criteria:-known diabetes mellitus
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Subjects identified from an outpatient (vascular, lipid) hospital-based group, with an intermediate risk of (pre)diabetes, as defined by an age >35 years, and additionally at least one criterion from the metabolic syndrome, or at least once an increased glucose or HbA1c value in the preceding two years, but these outside the range of diabetes/IGT
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gelre Ziekenhuis | Apeldoorn | Gelderland | 7334 DZ | Netherlands | ||
| University Medical Center Groningen |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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none retained
| Groningen |
| Provincie Groningen |
| 9700 RB |
| Netherlands |
| D006943 | Hyperglycemia |