Effect of Acarbose on Postprandial Lipoprotein Levels in Glucose Intolerant Patients

Cardiovascular Risk Factor Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Glucose Intolerance
• Hyperglycemia
• Postprandial Hyperglycemia

• NCT number: NCT02355509
• Study type: Interventional
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Status: Completed
• Phase: Phase 4
• Start date: January 2010
• Completion date: July 2014