Effect of Acarbose on Postprandial Lipoprotein Levels in Glucose Intolerant Patients

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.

Study Overview

• Status: Completed
• Conditions: Glucose Intolerance; Cardiovascular Risk Factor; Postprandial Hyperglycemia
• Intervention / Treatment: Drug: Placebo; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • Distrito Federal
    • México City, Distrito Federal, Mexico, 14000
      • Instituto Nacional de Ciencias Medicas y Nutricion, Salvador Zubiran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; A placebo drug is given for three months	Drug: Placebo; Placebo pills are given instead of acarbose in this group
Experimental: Acarbose; Acarbose is given for three months	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; Other Names: Glucobay

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Investigators: Principal Investigator: Fracisco J Gómez-Pérez, MD, PhD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: January 21, 2015
• First Submitted That Met QC Criteria: January 30, 2015
• First Posted (Estimate): February 4, 2015

Study Record Updates

• Last Update Posted (Estimate): February 9, 2015
• Last Update Submitted That Met QC Criteria: February 6, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Cardiovascular risk; Postprandial lipemia; Acarbose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Glycoside Hydrolase Inhibitors; Acarbose
• Other Study ID Numbers: REF.1467