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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| University of Padova | OTHER |
| Universidad Politecnica de Madrid | OTHER |
| University of Pavia |
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This study aims at improving the prediction of type 2 diabetes among high-risk individuals by examining glucose excursion patterns in subjects with impaired glucose tolerance. In addition, this study will show whether the currently used diagnostic test could be replaced by an easier and less expensive method.
Type 2 diabetes is a chronic disease of glucose metabolism leading to various disabling conditions. The onset of type 2 diabetes is a gradual shift from normal to abnormal, giving rarely noticeable symptoms at its early stages or even in later stages when damage has already been caused. Due to the gradual onset, the diagnosis is often delayed, and as much as half of the asymptomatic patients remain undetected. The diagnostic criteria for diabetes are based on artificial boundaries reflecting the risk of complications related to diabetes. The golden standard of diagnosis of diabetes is a 2 hours oral glucose tolerance test, which is both time consuming and costly. This study aims at improving the prediction of type 2 diabetes among high-risk individuals by examining glucose excursion patterns in subjects with impaired glucose tolerance. In addition, this study will show whether the currently used diagnostic test could be replaced by an easier and less expensive method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| subjects at the early stages of diabetes | Subjects at the early stages of diabetes, individuals with impaired glucose tolerance (IGT, 2h plasma glucose during oral glucose tolerance test >7.8-11.1 mmol/l (n=50) or with type 2 diabetes (fasting plasma glucose > 7.0 mmol/l and/or 2h plasma glucose > 11.1 mmol/l on two occasions, or both criteria fulfilled in same oral glucose tolerance test while not pregnant, n=50) with short duration (<3 years) |
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| Measure | Description | Time Frame |
|---|---|---|
| glucose levels in tissue fluid | continuous glucose monitoring system | continuous monitoring for 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| capillary glucose | for the calibration of the continuous glucose monitoring system | 4 times a day for 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals with impaired glucose tolerance (2h plasma glucose during oral glucose tolerance test >7.8-11.1 mmol/l, n=50) or with type 2 diabetes (fasting plasma glucose > 7.0 mmol/l and/or 2h plasma glucose > 11.1 mmol/l on two occasions, or both criteria fulfilled in the same oral glucose tolerance test while not pregnant, n=50) with short duration (<3 years); 40 from Padova University Hospital, 60 from the Botnia Study or the PPP-Botnia Study in Finland. The Botnia Study and the PPP-Botnia Study are population based studies investigating type 2 diabetes in western Finland.
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| Name | Affiliation | Role |
|---|---|---|
| Tiinamaija Tuomi, MD,lecturer | Folkhalsan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Folkhälsan Research Center | Helsinki | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24944918 | Background | Soliman A, DeSanctis V, Yassin M, Elalaily R, Eldarsy NE. Continuous glucose monitoring system and new era of early diagnosis of diabetes in high risk groups. Indian J Endocrinol Metab. 2014 May;18(3):274-82. doi: 10.4103/2230-8210.131130. | |
| 21854404 | Background | Wang C, Lv L, Yang Y, Chen D, Liu G, Chen L, Song Y, He L, Li X, Tian H, Jia W, Ran X. Glucose fluctuations in subjects with normal glucose tolerance, impaired glucose regulation and newly diagnosed type 2 diabetes mellitus. Clin Endocrinol (Oxf). 2012 Jun;76(6):810-5. doi: 10.1111/j.1365-2265.2011.04205.x. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
| Fondazione Salvatore Maugeri | OTHER |
| Asociación Española Para el Desarrollo de la Epidemiologia Clínica | UNKNOWN |
| Lund University | OTHER |
| Soluciones Tecnologias para la Salud y el Bienestar SA | UNKNOWN |
| National Technical University of Athens | OTHER |
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serum, plasma, urine
| D004700 | Endocrine System Diseases |