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20 Years Results by HBP and DBP in Patients With Type 2 Diabetes Mellitus After Following-up

NCT02569151 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2015-10-06

No results posted yet for this study

Summary

Participants were examined using the methods reported previous. All chemical laboratory data were obtained at each clinic visit in the morning in a non-fasting state. A single specimen at each visit was used to assess urinary albumin levels based on the 2009 guidelines of the ADA. CBP was measured once in each clinic visit. HBP was measured every day in the morning within 10 minutes after awakening in the sitting position, but HBP value assessed for this study used the value measured once in the same morning at each clinic visit.

Clinic hypertension (CH) and morning hypertension (MH) were defined as systolic BP (SBP) 130 mmHg and/or diastolic BP (DBP) 85 mmHg; clinic normotension (CN) and morning normotension (MN) were defined as SBP \<130 mmHg and DBP \<85 mmHg, respectively. The reason underlying that same threshold was used for both clinic and morning values was based on criteria of the 1999 WHO-International Society of Hypertension guidelines, because this study started in 1999. Based on HBP, subjects were divided into MH and MN patients, and anti-hypertensive drug use was determined in each group. In addition, based on CBP, subjects were divided into CH and CN patients. These patients were followed using the same methods used for MH and MN patients.

Outcome considered only the first event in each subject. Primary end-point was death from any cause. Secondary end-points were new, worsened, or improved microvascular and macrovascular events.

Risk factors related to each outcome were determined, and therapy which was added to baseline used for each disease in patients with MH was recorded at base- and end-points.

All results are presented as means ± SD. Mean values were compared using the paired or unpaired student t test. To compare the prevalence of events or medical treatment in patients with and without HT on basis of HBP or CBP, Fisher's exact test with two-tailed P values was used, and then hazard ratio and 95% confidence intervals were calculated.

Differences in outcomes between patients with HT and NT on basis of HBP or CBP at base- and end-points in the home or in the clinic, respectively, were assessed using Kaplan-Meier survival curves and then compared by hazard rate using the log-rank test.

Risk factors determined to be statistically related to outcomes were assessed by Cox proportional hazard analysis.

Conditions

Interventions

DEVICE

HBP & CBP measurement using systo 130 mmHg

Sponsors & Collaborators

  • Kyuzi Kamoi

    lead OTHER

Principal Investigators

  • Kyuzi Kamoi, MD · Jyoetsu General Hospital

Eligibility

Min Age
20 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2027-03-31
Completion
2027-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02569151 on ClinicalTrials.gov