Effect of Acarbose on Postprandial Lipoprotein Levels in Glucose Intolerant Patients

Cardiovascular Risk Factor Clinical Trial

Official title:

Effect of Acarbose on Postprandial Lipoprotein Levels in Glucose Intolerant Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02355509
• Other study ID #: REF.1467
• Status: Completed
• Phase: Phase 4
• First received: January 21, 2015
• Last updated: February 6, 2015
• Start date: January 2010
• Est. completion date: July 2014

Study information

• Verified date: February 2015
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Glucose Intolerance
• Hyperglycemia
• Postprandial Hyperglycemia

Intervention

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
• Placebo
Placebo pills are given instead of acarbose in this group

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán	México City	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change in LDL concentration	We measure basal LDL concentration in each patient, pre and post-treatment	3 months treatment	No
Secondary	Change in HDL concentration	We measure basal HDL concentration in each patient, pre and post-treatment	3 months treatment	No
Secondary	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	No