| Trial ID: | L4538 |
| Source ID: | NCT02235519
|
| Associated Drug: |
Azilsartan 40 Mg.
|
| Title: |
Pleiotropic Effects of Azilsartan Medoxomil Over Insulin Resistance in Obese, Diabetic and Hypertensive Patients
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hypertension|Obesity|Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Azilsartan 40 mg.|DRUG: Azilsartan 80 mg
|
| Outcome Measures: |
Primary: Blood pressure, Effect size of azilsartan medoxomil 40 and 80 mg in lowering systolic and diastolic blood pressure stratified by metabolic condition (obesity or type 2 diabetes mellitus). The minimal size effect between groups will be at least 30% and absolute percentage of previous hypertensive subjects reaching targeted values of \< 130/85 mmHg., 12 weeks | Secondary: Insulin sensitivity and HbA1c level, Effect over insulin sensitivity measured by Matsuda index of insulin sensitivity (ISI) and the level of HbA1c. The function will show a increase for ISI that in a within contrast will be larger for those with obesity with hypertension and diabetes. Meanwhile the HbA1 will show a deep decrease for the same group., 12 weeks|Effect of azilsartan on Inflammatory markers, Effect size between azilsartan 40 mg and 80 mg on inflammatory markers (IL-1b, IL-6, IL 10, TNF-α, and adiponectin). A decrease in this response will be more important for the 80 mg and those with obesity, hipertension and diabetes., 12 weeks|Endothelial function, Subjects with stiffness of the carotid and brachial artery will show improvement in relaxation, and the larger effect will be for 80 mg in the group of obesity, hypertension and diabetes mellitus., 12 weeks|Renal function improvement., Proteinuria will show a significant decrease after 12 weeks of treatment with azilsartan. The larger effect will be for the 80 mg and the obese, hypertension and diabetic group., 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Hospital General de México Dr. Eduardo Liceaga
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
300
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-01
|
| Completion Date: |
2015-06
|
| Results First Posted: |
|
| Last Update Posted: |
2015-03-30
|
| Locations: |
Hospital General de Mexico "Dr. Eduardo Liceaga", Mexico, Mexico, D.F., 06720, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT02235519
|
