NCT02355509

Effect of Acarbose on Postprandial Lipoprotein Levels in Glucose Intolerant Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glucose Intolerance
• Postprandial Hyperglycemia
• Cardiovascular Risk Factor

Interventions

Type	Name	Description
DRUG	Acarbose	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
DRUG	Placebo	Placebo pills are given instead of acarbose in this group

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2015-02-04
• Last updated: 2015-02-09

Locations

1 site across 1 country: Mexico