Trial Condition(s):
Prevent/delay development of type 2 diabetes in subjects with impaired glucose homeostasis treated with Acarbose in Primary Care
10139
Not Available
Not Available
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.
- Age > 40 and < 75 years old - Men and women - Able to give voluntary informed consent - Existence of one or more of the following risk factors: - Body Mass Index (BMI) > 27 mg/Kg2 - One or more family members with diabetes determined by anamnesis. - Personal antecedents of previous blood glucose anomalies (gestational diabetes reverted after the lactation time, before-during surgical stress, fasting glycaemia > 110 mg/dL (6,1 mM) and < 126 mg/dL (7 mM) registered in the Clinical History during the last 3 years, etc.) - Previous consumption of drugs with hyperglycaemic capacity for a period of 3 months continuously or more than 6 months discontinuously
- Type 2 DM - Pregnancy during the study - Nursing women - Major debilitating (e.g. collagen vascular diseases, failure of major organ, psychosis, severe infections, neutropenia, BMI < 20 mg/Kg2) - Subjects taking a prohibited drug (see protocol) - Subjects taking drugs that can impair intestinal motility and/or carbohydrate absorption (i.e. cholestyramine, neomycin) - Recent cardiovascular events (within last 6 months) such as myocardial infarction, cerebrovascular accident, congestive heart failure - Serum creatinine > 2 mg/Dl - Fasting triglycerides > 10 mm/L (> 885 mg/dL) - AST elevation > 2.5 times above the upper limit of normal - Subjects with hyper/hypothyroidism non compensated - Subjects with documented gastrointestinal diseases that are likely to be associated with abnormal intestinal motility or altered absorption of nutrients (e.g. gastroparesia, malabsorption syndrome, chronic diarrhoea states, enteropathies, inflammatory bowel diseases, partial intestinal obstruction, large hernias) - Subjects with any emotional disorder or substance abuse (e.g. severe depression, alcohol or drug abuse) - Hypersensitivity to Acarbose
Locations | |
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Locations Area Bàsica de Salud Reus 2 Reus, Spain, 43202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Area Bàsica de Salud Reus 1 Reus, Spain, 43202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Area Bàsica de Salud Reus 4 Reus, Spain, 43203 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Area Bàsica de Salud Borges del Camp Les Borges del Camp, Spain, 43350 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Area Bàsica de Salud Cornudella Cornudella, Spain, 43360 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Area Bàsica de Salud Constantí Constanti, Spain, 43120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre d'Atenció Primària El Temple Tortosa, Spain, 43500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Salud Novelda (Area 17) Novelda, Spain, 03660 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Salud de Crevillente (Area 19) Crevillente, Spain | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Salud Begonte Begonte, Spain, 27373 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Salud Mar Báltico Madrid, Spain, 28033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Area Bàsica de Salud Reus 3 - CAP Sant Pere Reus, Spain, 43201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Area Basica de Salud Vinebre Vinebre, Spain, 43729 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Area Bàsica de Salud Falset Falset, Spain, 43730 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Area Bàsica de Salud Torreforta - La Granja Tarragona, Spain, 43006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Area Bàsica de Salud El Morell El Morell, Spain, 43760 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre d'Atenció Primària Jaume I Tarragona, Spain, 43005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Salud Agost (Area 18) Agost, Spain, 03698 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Salud La Florida Alicante, Spain, 03007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Salud San Vicente de Raspeig (Area 18) San Vicente del Raspeig, Spain, 03690 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Salud Villalba Villalba, Spain, 27800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de saluld de camas Camas, Spain, 41900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Salud Trobajo del Camino Trobajo del Camino, Spain, 24010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CAP Terrassa Sud Terrassa, Spain, 08223 | Contact Us: E-mail: [email protected] Phone: Not Available |
A multi-centre, parallel, double-blind, randomised and placebo controlled Spanish study, to prevent or delay the development of type 2 diabetes in subjects with impaired glucose homeostasis treated with Acarbose in Primary Care (PREDIAP)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2