Clinical Trial to Assess the Effects of Candesartan on the Carbohydrate Metabolism of Obese Subjects
Status:
Terminated
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
Hypothesis:
The use of candesartan 16-32 mg/d for 6 months improves the carbohydrate metabolism, and
decreases the plasmatic levels of adipocytokines and oxidative stress markers, in non
diabetic, non hypertensive subjects with dysglycemia and abdominal obesity, and these effects
are independent of the changes in arterial blood pressure.
General Objectives:
The objective is to study the impact of the treatment with candesartan in the carbohydrate
metabolism and the plasmatic levels of adipocytokines and oxidative stress markers, in non
diabetic, non hypertensive subjects with dysglycemia and abdominal obesity.
Study Design:
This is a randomized, double blind, cross-over, placebo-controlled, clinical trial to assess
the effects of candesartan (up to 32 mg/d for 6 months), over the carbohydrate metabolism,
plasma levels of adipocytokines and concentrations of oxidative stress markers in non
diabetic, non hypertensive, dysglycemic and obese subjects from Colombia. The total duration
of the study is 36 months.
Population:
One hundred non diabetic, dysglycemic and obese, subjects of both genders, over 18 years old,
will be included. To be included subjects should have blood pressure values under 140/90 mmHg
and should be receiving no antihypertensive medical treatment.
Procedures:
Subjects whom fulfill all selection criteria will be included in a run-in period of 15 days
with placebo and hygiene-dietary measures (MHD) including educational, nutritional and
exercise support. The patients that during this "Run in" phase have a compliance equal to or
greater than 80% will be randomized to one of the two treatment groups ("Group A" receiving
candesartan 16/32 mg/d for 6 months and then placebo for 6 months, or "Group B" receiving
placebo during the first 6 months and then candesartan 16/32 mg/d during the last 6 months)
in a 1:1 proportion by blocks of 4 subjects. Randomization will be performed by the
AstraZeneca clinical department. Both groups will concurrently receive the standard treatment
with MHD. Control visits will be programmed every month. Metabolic parameters, including
C-reactive protein (CRP), interleukin-6 (IL-6), adiponectin, leptin, insulin, malonaldehyde
and 8-isoprostanes, will be evaluated every 6 months (at the beginning and end of each
treatment).
Statistical Analysis:
The analysis strategy will be performed by intention-to-treat. In a descriptive analysis, the
averages and proportions will be obtained with their corresponding 95% confidence intervals
for the clinically relevant variables during the baseline evaluation. In order to evaluate
the differences between the groups, the Student's t test, Mann-Whitney and Fischer's exact
tests will be used according to the nature of the study variables. Multiple lineal regression
will be used with the purpose of comparing the treatment groups from baseline and its changes
up to the 6th month of treatment.
Ethical Aspects:
The study will be conducted according to the Helsinki declaration, the good clinical
practices guidelines and the Colombian legislation. Prior to entering the study, patients
must sign a written informed consent that has been approved by the Institutional Ethics
Committee of Fundación Cardiovascular de Colombia.