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Metadata

Name
20 Years Results by HBP and DBP in Patients With Type 2 Diabetes Mellitus After Following-up
Repository
ClinicalTrials.gov
Identifier
clinicaltrials:NCT02569151
Description
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.
Data or Study Types
clinical trial
Source Organization
Unknown
Access Conditions
available
Year
2015
Access Hyperlink
https://clinicaltrials.gov/ct2/show/NCT02569151

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