Diabetes Mellitus
Conditions
Keywords
Metabolic Disease, IGT Impaired Glucose Tolerance
Brief summary
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.
Interventions
50 mg TID
DRUGPlacebo
50 mg TID
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Evolution of the cardiovascular risk markers (microalbuminuria, triglycerides, fasting glycaemia, after overload glycaemia, HbA1c, C-peptide, insulinemia) | Three years and three months. |
| Evolution of blood pressure | Three years and three months. |
| Evolution of lipid profile | Three years and three months. |
| Regression to the normality (NO impaired glucose homeostasis) | Proportion of subjects that had regressed to normality after three years of treatment. |
| 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 |
| Evolution of anthropometric measurements | Three years and three months. (BMI) |
Countries
Spain
Outcome results
None listed