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Accomplices of Insulin Resistance in Prehypertension: Aldosterone?

5 december 2011 uppdaterad av: vghtpe user, Taipei Veterans General Hospital, Taiwan

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

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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

43

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Taiwan
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Renin and aldosterone responses in postural stimulation tests
Tidsram: 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
2 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The differences in post-challenge renin and aldosterone responses in the oral glucose tolerance
Tidsram: 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 weeks
Correlations of renin and aldosterone with insulin sensitivity
Tidsram: 2 weeks
Pearson and partial correlation procedures will be used to test the correlations of renin and aldosterone with insulin sensitivity.
2 weeks
Correlations of renin and aldosterone with blood pressure
Tidsram: 2 weeks
Pearson and partial correlation procedures will be used to test the correlations of renin and aldosterone with blood pressure.
2 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Taipei Veterans General Hospital, Taiwan

Utredare

  • Huvudutredare: Chii-Min Hwu, MD, Section of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2010

Primärt slutförande (Faktisk)

1 juli 2011

Avslutad studie (Faktisk)

1 juli 2011

Studieregistreringsdatum

Först inskickad

26 april 2010

Först inskickad som uppfyllde QC-kriterierna

27 april 2010

Första postat (Uppskatta)

28 april 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

6 december 2011

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 december 2011

Senast verifierad

1 december 2011

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • V99C1-153

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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