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| ID | Type | Description | Link |
|---|---|---|---|
| PREDIAP |
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The purpose of the study is to determine if the administration of small doses of Acarbose can prevent or delay the appearance of Type 2 Diabetes Mellitus in a population of subjects with prediabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acarbose (Glucobay, BAYG5421) | Drug | 50 mg TID |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The principal objective was to determine if the administration of small doses of Acarbose could prevent or delay the appearance of Type 2 DM in a population of subjects with impaired glucose homeostasis. | The main criterion for the evaluation of the primary objective was the proportion of diabetic subjects after three years of treatment and another time after three months of wash-out with placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| Regression to the normality (NO impaired glucose homeostasis) | Proportion of subjects that had regressed to normality after three years of treatment. | |
| Evolution of the cardiovascular risk markers (microalbuminuria, triglycerides, fasting glycaemia, after overload glycaemia, HbA1c, C-peptide, insulinemia) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agost | Alicante | 03698 | Spain | |||
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| Drug |
50 mg TID |
|
| Three years and three months. |
| Evolution of blood pressure | Three years and three months. |
| Evolution of lipid profile | Three years and three months. |
| Evolution of anthropometric measurements | Three years and three months. (BMI) |
| The appearance or progression of cardiovascular events: angina, myocardial infarction, cerebrovascular accident, congestive heart failure, peripheral vascular disease, revascularisation procedure | Time until the appearance or progression of cardiovascular episodes |
| Delay in the conversion to diabetes mellitus | Time until the confirmation of the diagnosis of Diabetes Mellitus |
| Alicante |
| Alicante |
| 03007 |
| Spain |
| Crevillent | Alicante | Spain |
| Novelda | Alicante | 03660 | Spain |
| San Vicent del Raspeig | Alicante | 03690 | Spain |
| Terrassa | Barcelona | 08223 | Spain |
| Trobajo del Camino | León | 24010 | Spain |
| Begonte | Lugo | 27373 | Spain |
| Villalba | Lugo | 27800 | Spain |
| Madrid | Madrid | 28033 | Spain |
| Camas | Sevilla | 41900 | Spain |
| Constantí | Tarragona | 43120 | Spain |
| Cornudella | Tarragona | 43360 | Spain |
| el Morell | Tarragona | 43760 | Spain |
| Falset | Tarragona | 43730 | Spain |
| les Borges del Camp | Tarragona | 43350 | Spain |
| Reus | Tarragona | 43201 | Spain |
| Reus | Tarragona | 43202 | Spain |
| Reus | Tarragona | 43203 | Spain |
| Tarragona | Tarragona | 43005 | Spain |
| Tarragona | Tarragona | 43006 | Spain |
| Tortosa | Tarragona | 43500 | Spain |
| Vinebre | Tarragona | 43729 | Spain |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D008659 | Metabolic Diseases |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |
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| ID | Term |
|---|---|
| D020909 | Acarbose |
| ID | Term |
|---|---|
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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