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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
Sponsor:
Information provided by (Responsible Party):

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
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 : April 2010
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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 :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  1. Men or women aged 20 - 70 years old.
  2. 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.
  3. Willing to participate by signing an informed consent.
  4. Willing to undergo two clinical tests at two separate visits.

Exclusion Criteria:

  1. Patients with known history of type 2 diabetes or fasting plasma glucose greater than 126 mg/dL.
  2. Patients with known history of hypertension.
  3. History of major renal, liver, heart, blood and neurological disease.
  4. History of alcoholism or drug abuse.
  5. Women who are pregnant.
  6. 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.
  7. 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.
  8. Difficult venous access.
Contacts and Locations

Information from the National Library of Medicine

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


Locations
Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Chii-Min Hwu, MD Section of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital
More Information

Responsible Party: vghtpe user, Attending physician, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier: NCT01112007     History of Changes
Other Study ID Numbers: V99C1-153
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: December 6, 2011
Last Verified: December 2011

Keywords provided by vghtpe user, Taipei Veterans General Hospital,Taiwan:
Insulin Resistance
Hypertension
Blood pressure
Aldosterone
Renin

Additional relevant MeSH terms:
Hypertension
Insulin Resistance
Prehypertension
Vascular Diseases
Cardiovascular Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs