Status:
TERMINATED
Clinical Trial to Assess the Effects of Candesartan on the Carbohydrate Metabolism of Obese Subjects
Lead Sponsor:
Fundación Cardiovascular de Colombia
Collaborating Sponsors:
AstraZeneca
Conditions:
Glucose Intolerance
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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, no...
Detailed Description
Background: During the last years, the worldwide prevalence of diabetes mellitus type II (DM2) has increased dramatically, impacting the cardiovascular morbidity and mortality. It has been estimated ...
Eligibility Criteria
Inclusion
- The subjects that fulfill the following inclusion criteria will be eligible to participate in the study:
- Men and women older than 18 years of age.
- Waist perimeter \> 90 cm in males or \> 80 cm in females
- Have plasma glucose levels in fasting between 100 and 125 mg/dL and/or on glucose tolerance test at 2 hours \> 140 mg/dL and \< 200 mg/dL.
- Having a treatment compliance of over 80% at the end of the run-in phase.
- All women with childbearing potential must have a secure contraceptive method. A secure method will be considered as sterilization by surgical methods, postmenopausal condition with an age greater than 45 years and a menopausal period equal to or greater than two years. In premenopausal women, the use of two barrier contraceptive methods including 1 month after the conclusion of the active phase of study treatment.
Exclusion
- Individuals with any of the following characteristics will be excluded:
- Prior diagnosis of type 1 or 2 diabetes mellitus, chronic or acute renal insufficiency, coronary disease clinically evident (acute myocardial infarction, chest angina, myocardial revascularization) or cardiac insufficiency, or history of prior cardiovascular events (AMI, CVD, or CABG).
- Significant chronic disease (terminal stage cirrhosis or hepatic disease or cancer) that affects the survival of patients at 12 months.
- Chronic inflammatory diseases of obesity (lupus erythematosus, rheumatoid arthritis, etc.)
- Infectious acute or chronic processes of any etiology with an occurrence within the 4 weeks prior to the beginning of the study.
- Use of steroid hormones or NSAIDs 1 month prior to the beginning of the study.
- The patient is participating in a program or under treatment to lose weight during the 8 weeks prior to the study entry.
- The patient requires (for any circumstance) treatment with immunosuppressive agents.
- Has participated in a clinical trial in the 8 weeks prior to the study entry.
- At the study entry, the patient is considering the possibility of a surgical procedure during the next 12 months.
- History of severe chronic gastritis or any condition of the gastrointestinal tract that may affect the absorption and/or distribution of any drug administered orally.
- Alteration of the hepatic function tests. The maximum value for ALT or AST will be considered as \> 2 times the upper normal limit.
- Triglycerides \> 600 mg/dl.
- History of the use of psychoactive drugs or abuse of alcohol.
- Positive pregnancy test in the screening visit.
- Concomitant treatment with any other antihypertensive drug.
- Contraindication to receive treatment with candesartan.
- Pathological alterations of aortic or mitral cardiac valves (stenosis or insufficiency) or hypertrophic cardiomyopathy.
- Denial to sign informed consent, or any mental condition that makes the patient part of a susceptible population
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00319202
Start Date
June 1 2006
End Date
February 1 2012
Last Update
November 6 2012
Active Locations (1)
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1
Fundación Cardiovascular de Colombia
Floridablanca, Santander Department, Colombia, 10000