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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02355509
Other study ID # REF.1467
Secondary ID
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


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
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