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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
204
50 mg TID
50 mg TID
Unnamed facility
Agost, Alicante, Spain
Unnamed facility
Alicante, Alicante, Spain
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.
Time frame: 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.
Regression to the normality (NO impaired glucose homeostasis)
Time frame: 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)
Time frame: Three years and three months.
Evolution of blood pressure
Time frame: Three years and three months.
Evolution of lipid profile
Time frame: Three years and three months.
Evolution of anthropometric measurements
Time frame: 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 frame: Time until the appearance or progression of cardiovascular episodes
Delay in the conversion to diabetes mellitus
Time frame: Time until the confirmation of the diagnosis of Diabetes Mellitus
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Unnamed facility
Crevillent, Alicante, Spain
Unnamed facility
Novelda, Alicante, Spain
Unnamed facility
San Vicent del Raspeig, Alicante, Spain
Unnamed facility
Terrassa, Barcelona, Spain
Unnamed facility
Trobajo del Camino, León, Spain
Unnamed facility
Begonte, Lugo, Spain
Unnamed facility
Villalba, Lugo, Spain
Unnamed facility
Madrid, Madrid, Spain
...and 13 more locations