Accomplices of Insulin Resistance in Prehypertension: Aldosterone?

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Completed

CT.gov ID

NCT01112007

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purposes of the study are to evaluate the relative contributions of insulin resistance and renin-angiotensin-aldosterone system to blood pressure (BP) in subjects with prehypertension. This is a cross-sectional study. Anthropometric and BP measurements will be performed in 50 prehypertensive subjects. The subjects will receive a 75-g oral glucose tolerance test and a postural stimulation test for the measurements of insulin resistance, plasma rennin concentration and aldosterone level. Log (ISI0,120), an insulin sensitivity index from the oral glucose tolerance test, will be calculated. Statistical analyses will be performed to compare the degree to which aldosterone and Log (ISI0,120) predicted systolic and diastolic BP in these prehypertensive subjects.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Insulin Resistance

Detailed Description

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 Design

Study Type:

Observational

Actual Enrollment :

43 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Searching for Accomplices in the Transgression of Insulin Resistance in Prehypertension: Aldosterone?

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
prehypertension Subjects with prehypertension, that is, individuals with systolic blood pressure in the range of 120-139 mmHg or diastolic BP between 80-89 mmHg.

Outcome Measures

Primary Outcome Measures

Renin and aldosterone responses in postural stimulation tests [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

Secondary Outcome Measures

The differences in post-challenge renin and aldosterone responses in the oral glucose tolerance [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 [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 [2 weeks]
Pearson and partial correlation procedures will be used to test the correlations of renin and aldosterone with blood pressure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Men or women aged 20 - 70 years old.
Subjects with prehypertension,; that is, individuals with systolic blood pressure (BP) in the range of 120-139 mmHg or diastolic BP between 80-89 mmHg.
Willing to participate by signing an informed consent.
Willing to undergo two clinical tests at two separate visits.

Exclusion Criteria:

Patients with known history of type 2 diabetes or fasting plasma glucose greater than 126 mg/dL.
Patients with known history of hypertension.
History of major renal, liver, heart, blood and neurological disease.
History of alcoholism or drug abuse.
Women who are pregnant.
Current or concomitant illness that would interfere with the subject's ability to perform the study or that would confound the study results, judged by the investigation physicians.
Any concomitant BP-lowering, anti-lipid, and glucose-modification agents within 2 weeks of the study, and oral contraceptives and estrogen therapy within 8 weeks of the study.
Difficult venous access.