Clinical Trial to Assess the Effects of Candesartan on the Carbohydrate Metabolism of Obese Subjects (ARAMIA)
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.
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.
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.
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.
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).
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.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double Blind, Cross-Over, Placebo-Controlled Clinical Trial to Assess the Effects of Candesartan on the Carbohydrate Metabolism, of Non Diabetic, Non Hypertensive Subjects With Dysglycemia and Abdominal Obesity."ARAMIA"|
- Changes in HOMA index value [ Time Frame: 6 months after beginning the treatment ] [ Designated as safety issue: No ]
- Changes in serum insulin, leptin and adiponectin, inflammatory markers and oxidative stress markers [ Time Frame: 6 months after beginning the treatment ] [ Designated as safety issue: No ]
- Changes in baseline glucose, and post-charge glucose plasma levels [ Time Frame: 6 months after beginning the treatment ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
32 mg/d for 6 months
|Placebo Comparator: 2||
Placebo administration for 6 months
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319202
|Fundación Cardiovascular de Colombia|
|Floridablanca, Santander, Colombia, 10000|
|Principal Investigator:||Ronald G Garcia Gomez, MD, PhD||Research Institute/Fundación Cardiovascular de Colombia|
|Study Chair:||Vicente Lahera, PhD||Departamento de Fisiologia/Universidad Complutense de Madrid|
|Study Chair:||Federico A Silva, MD||Research Institute/Fundación Cardiovascular de Colombia|
|Study Chair:||Gustavo Marques, MD||Research Institute/Fundación Cardiovascular de Colombia|