Accomplices of Insulin Resistance in Prehypertension: Aldosterone?
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|ClinicalTrials.gov Identifier: NCT01112007|
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : December 6, 2011
|Condition or disease|
|Hypertension Insulin Resistance|
Background: Prehypertension, a new category of blood pressure (BP) classification introduced by The Seven Report of the Joint National Commission (JNC-7) on High BP for individuals with systolic BP in the range of 120-139 mmHg or diastolic BP between 80-89 mmHg, is a strong predictor for the development of hypertension. Insulin resistance (IR) is reported to be associated with prehypertension. Activation of the renin-angiotensin-aldosterone (RAA) system is a major player in IR and elevation of high BP.
Aim: The purposes of the study are to evaluate the interactions of IR-RAA and their relative contributions to BP in subjects with prehypertension.
Design: This is a cross-sectional study. Methods: Anthropometric and BP measurements will be performed in 50 prehypertensive subjects. The subjects will receive a 75-g oral glucose tolerance test (OGTT) and a postural stimulation test for the measurements of IR, plasma rennin concentration (PRC) and aldosterone level. The study participants will be divided into three subgroups by tertiles of Log (ISI0,120), an insulin sensitivity index from the OGTT. Analysis of variance (ANOVA) will be applied to compare the differences in clinical characteristics among the three groups. Univariate analyses of general linear models will be used to compare the differences in PRC, aldosterone, and aldosterone/rennin ratio (ARR) in postural stimulation tests among the three subgroups, showing effects of confounding variables including age, sex, BMI and physical inactivity scores. Repeated-measures ANOVA will be used to assess the differences in post-challenge PRC, aldosterone, and ARR responses in the OGTT with or without adjustments of the above covariates. Pearson and partial correlation procedures will be used to test the correlations of PRC, aldosterone, ARR with insulin sensitivity and BP. Multiple linear regression models will be used in an attempt to compare the degree to which aldosterone (or ARR) and Log (ISI0,120) predicted systolic and diastolic BP in these prehypertensive subjects.
Expected results and contributions: We hope the study can explore the contribution of the IR-RAA interactions to BP in subjects with prehypertension.
|Study Type :||Observational|
|Actual Enrollment :||43 participants|
|Official Title:||Searching for Accomplices in the Transgression of Insulin Resistance in Prehypertension: Aldosterone?|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Subjects with prehypertension, that is, individuals with systolic blood pressure in the range of 120-139 mmHg or diastolic BP between 80-89 mmHg.
- Renin and aldosterone responses in postural stimulation tests [ Time Frame: 2 weeks ]The differences in renin and aldosterone responses in postural stimulation tests among the three subgroups, showing effects of confounding variables including age, sex, body mass index (BMI) and physical inactivity scores
- The differences in post-challenge renin and aldosterone responses in the oral glucose tolerance [ Time Frame: 2 weeks ]Repeated-measures analysis of variance (ANOVA) will be used to assess the differences in post-challenge renin and aldosterone responses in the oral glucose tolerance test with or without adjustments.
- Correlations of renin and aldosterone with insulin sensitivity [ Time Frame: 2 weeks ]Pearson and partial correlation procedures will be used to test the correlations of renin and aldosterone with insulin sensitivity.
- Correlations of renin and aldosterone with blood pressure [ Time Frame: 2 weeks ]Pearson and partial correlation procedures will be used to test the correlations of renin and aldosterone with blood pressure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112007
|Taipei Veterans General Hospital|
|Taipei, Taiwan, 112|
|Principal Investigator:||Chii-Min Hwu, MD||Section of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital|