Clinical trial NCT02355509: Effect of Acarbose on Postprandial Lipoprotein Levels in Glucose Intolerant Patients
Official title: Effect of Acarbose on Postprandial Lipoprotein Levels in Glucose Intolerant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glucose Intolerance
Postprandial Hyperglycemia
Cardiovascular Risk Factor
Keywords: Acarbose
Postprandial lipemia
Cardiovascular risk
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in postprandial oxLDL
timeFrame: 3 months treatment
Secondary outcomes:
measure: Chance in postprandial hyperglycemia
timeFrame: 3 months treatment
measure: Chance in postprandial insulin levels
timeFrame: 3 months treatment
measure: Change in LDL concentration
timeFrame: 3 months treatment
measure: Change in HDL concentration
timeFrame: 3 months treatment
measure: Change in Apolipoprotein B (ApoB) concentration
timeFrame: 3 months treatment
Other outcomes:
Locations:
city: México City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán
state: Distrito Federal
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Fracisco J Gómez-Pérez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: