Effect of Acarbose on Postprandial Lipoprotein Levels in Glucose Intolerant Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Acarbose on Postprandial Lipoprotein Levels in Glucose Intolerant Patients

Conditions
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Glucose Intolerance, Postprandial Hyperglycemia, Cardiovascular Risk Factor

Intervention / Treatment
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* Drug: Acarbose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>A placebo drug is given for three months | Drug: Placebo<br>* Placebo pills are given instead of acarbose in this group<br>|
| Experimental: Acarbose<br>Acarbose is given for three months | Drug: Acarbose<br>* 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<br>* Other names: Glucobay;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postprandial oxLDL | 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 | 3 months treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chance in postprandial hyperglycemia | 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 | 3 months treatment | 
| Chance in postprandial insulin levels | 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 | 3 months treatment | 
| Change in LDL concentration | We measure basal LDL concentration in each patient, pre and post-treatment | 3 months treatment | 
| Change in HDL concentration | We measure basal HDL concentration in each patient, pre and post-treatment | 3 months treatment | 
| Change in Apolipoprotein B (ApoB) concentration | In each subject ApoB is measured, using nephelometry, at 0 and 300 minutes in a postprandial 5 hour test, pre and post-treatment | 3 months treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acarbose, Postprandial lipemia, Cardiovascular risk