- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01112007
Accomplices of Insulin Resistance in Prehypertension: Aldosterone?
Searching for Accomplices in the Transgression of Insulin Resistance in Prehypertension: Aldosterone?
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Taipei, Taiwan, 112
- Taipei Veterans General Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Renin and aldosterone responses in postural stimulation tests
Lasso di tempo: 2 weeks
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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
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2 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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The differences in post-challenge renin and aldosterone responses in the oral glucose tolerance
Lasso di tempo: 2 weeks
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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.
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2 weeks
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Correlations of renin and aldosterone with insulin sensitivity
Lasso di tempo: 2 weeks
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Pearson and partial correlation procedures will be used to test the correlations of renin and aldosterone with insulin sensitivity.
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2 weeks
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Correlations of renin and aldosterone with blood pressure
Lasso di tempo: 2 weeks
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Pearson and partial correlation procedures will be used to test the correlations of renin and aldosterone with blood pressure.
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2 weeks
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Chii-Min Hwu, MD, Section of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- V99C1-153
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .