Effect of Acarbose on Postprandial Lipoprotein Levels in Glucose Intolerant Patients

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status and phase: Completed; Phase 4

Conditions: Postprandial Hyperglycemia; Cardiovascular Risk Factor; Glucose Intolerance

Treatments: Drug: Acarbose; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02355509

REF.1467

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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21 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

A placebo drug is given for three months

Treatment:

Drug: Placebo

Acarbose

Experimental group

Description:

Acarbose is given for three months

Treatment:

Drug: Acarbose