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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT02355509
Date of registration: 21/01/2015
Prospective Registration: No
Primary sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Public title: Effect of Acarbose on Postprandial Lipoprotein Levels in Glucose Intolerant Patients
Scientific title: Effect of Acarbose on Postprandial Lipoprotein Levels in Glucose Intolerant Patients
Date of first enrolment: January 2010
Target sample size: 21
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT02355509
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Mexico
Contacts
Name:     Fracisco J Gómez-Pérez, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Glucose Intolerance
Cardiovascular Risk Factor
Postprandial Hyperglycemia
Intervention(s)
Drug: Acarbose
Drug: Placebo
Primary Outcome(s)
Change in postprandial oxLDL [Time Frame: 3 months treatment]
Secondary Outcome(s)
Change in HDL concentration [Time Frame: 3 months treatment]
Change in Apolipoprotein B (ApoB) concentration [Time Frame: 3 months treatment]
Change in LDL concentration [Time Frame: 3 months treatment]
Chance in postprandial insulin levels [Time Frame: 3 months treatment]
Chance in postprandial hyperglycemia [Time Frame: 3 months treatment]
Secondary ID(s)
REF.1467
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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