Cardiovascular Risk Factor, Glucose Intolerance, Postprandial Hyperglycemia
Conditions
Keywords
Acarbose, Postprandial lipemia, Cardiovascular risk
Brief summary
Is a randomized, double-blind, placebo-controlled trial to determine the behavior of hyperglycemia and postprandial lipemia after a standard mixed meal load in patients with carbohydrate intolerance treated with acarbose.
Detailed description
To gather our patients, we invite the relatives of diabetic patients seen at the endocrinology consultation to participate in the study. * Patients are placed into an isocaloric diet for 4 weeks before the study and are advised not to change their baseline physical activity. * Patients are randomized to receive acarbose or placebo for 3 months blinded to investigators and patients. * Acarbose dose is progressively titrated (50 mg/day per week up to 150 mg/day) to reduce the known adverse effects of acarbose such as flatulence, bloating, diarrhea, abdominal pain. * In each subject, a 5-hr-postprandial mixed meal test is performed at baseline and after assigned treatment was completed. Glucose, insulin, triglycerides and total cholesterol were measured at 0, 5, 10, 20, 30, 60, 120, 180, 240 and 300 minutes after the mixed meal load. Apo B was measured by nephelometry and oxLDL using a monoclonal antibody 4E6 based competition (ELISA assay, Mercodia) at 0 and 300 minutes. * The standard mixed meal load, a 470 kcal breakfast, (47.76% carbohydrate, 22.66% proteins, 29.58% fat), consisted of: 1 sandwich (prepared with 50 g of Savory´s™ turkey breast ham, 30 g of Savory´s™ panela cheese, 2 tablespoons of Hellmann's™ mayonnaise and 2 slices of Bimbo´s™ white bread), 100 g of Red DeliciousTM apple and 250 mL of Alpura´s™ lactose-free, light milk. * During the 3-month treatment, patients have 3 follow-up monthly consultations to evaluate weight gain and treatment compliance.
Interventions
DRUGAcarbose
Acarbose dose was progressively titrated (50 mg/day per week up to 150 mg/day) to reduce the known adverse effects of acarbose such as flatulence, bloating, diarrhea, abdominal pain. The treatment for three months
DRUGPlacebo
Placebo pills are given instead of acarbose in this group
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recent diagnosis of carbohydrate intolerance according to the WHO criteria, without any treatment.
Exclusion criteria
* patients with BMI \>32 kg/m2, triglycerides and/or total cholesterol \> 300 mg/dl, known renal, liver or gastrointestinal disease and positive smoking.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in postprandial oxLDL | 3 months treatment | In each subject oxLDL is measured using a monoclonal antibody 4E6 based competition (ELISA assay, Mercodia) at 0 and 300 minutes in a postprandial 5 hour test, pre and post-treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chance in postprandial hyperglycemia | 3 months treatment | A 5 hour postprandial test is performed in each patient, were glucose is measured at 0, 5, 10, 20, 30, 60, 120, 180, 240 and 300 minutes, pre and post-treatment |
| Chance in postprandial insulin levels | 3 months treatment | A 5 hour postprandial test is performed in each patient, were insulin is measured at 0, 5, 10, 20, 30, 60, 120, 180, 240 and 300 minutes, pre and post-treatment |
| Change in LDL concentration | 3 months treatment | We measure basal LDL concentration in each patient, pre and post-treatment |
| Change in HDL concentration | 3 months treatment | We measure basal HDL concentration in each patient, pre and post-treatment |
| Change in Apolipoprotein B (ApoB) concentration | 3 months treatment | In each subject ApoB is measured, using nephelometry, at 0 and 300 minutes in a postprandial 5 hour test, pre and post-treatment |
Countries
Mexico
Outcome results
None listed