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Completed

NCT Number: NCT02355509

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán

Mexico City, 14000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acarbose

Drug

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

Placebo

Drug

Placebo pills are given instead of acarbose in this group

Primary outcomes

  1. Change in postprandial oxLDL

    Time frame: 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 outcomes

  1. Chance in postprandial hyperglycemia

    Time frame: 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

  2. Chance in postprandial insulin levels

    Time frame: 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

  3. Change in LDL concentration

    Time frame: 3 months treatment

    We measure basal LDL concentration in each patient, pre and post-treatment

  4. Change in HDL concentration

    Time frame: 3 months treatment

    We measure basal HDL concentration in each patient, pre and post-treatment

  5. Change in Apolipoprotein B (ApoB) concentration

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2015
Registry last updated
Feb 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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