Diabetes Mellitus Clinical Trial
Official title:
USEFULNESS OF MORNING HOME BLOOD PRESSURE MEASUREMENTS IN JAPANESE PATIENTS WITH TYPE 2 DIABETES MELLITUS: RESULTS OF A 20-YEARS, PROSPECTIVE, LONGITUDINAL STUDY
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.
Microalbuminuria and clinical albuminuria were defined as urinary albumin excretion rate 30
mg/g creatinine and 300 mg/g creatinine, respectively (6).
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. .
Microvascular complications included nephropathy, neuropathy, and retinopathy. Severity of
nephropathy was determined based on albuminuria using four categories: normal, 0 points;
microalbuminuria, 1 point; clinical albuminuria, 2 points; and dialysis, 3 points. Severity
of neuropathy was categorized as normal, 0 points; chronic sensorimotor distal symmetric
polyneuropathy and/or cardiac autonomic neuropathy, 1 point. Severity of retinopathy was
determined using four categories: normal, 0 points; simple, 1 point; pre-proliferative, 2
points; and proliferative, 3 points. Development of new, worsened, or improved
microangiopathy was defined according to a change of at least one step from baseline.
Macrovascular complications included coronary heart disease, cerebrovascular disease and
peripheral artery obstruction. Severity of macrovascular events was categorized using two
categories: normal, 0 points; and coronary heart disease, cerebrovascular disease, or
peripheral artery obstruction, 1 point (3). New, worsened (recurrent), or improved events
were defined based on clinical manifestations and treatment throughout the study.
For ethical reasons, patients were treated with various anti-hypertensive, anti-diabetic,
anti-dyslipidemia, anti-hypercoagulation and other agents during course of the study by
their own doctors.
Outcome results considered only the first event in each subject (3). Primary end-point was
death from any cause (3). Secondary end-points were new, worsened, or improved microvascular
and macrovascular events (3).
4) Risk factor assessment for outcomes. Risk factors at end-point in ? participants related
to each outcome were determined, and therapy which was added to baseline therapy used for
each disease in patients with MH was recorded at base- and end-points (3). The 6-month
interval minimizes bias due to the fall or rise in the HBP or CBP measurement (10).
Statistical analysis.
1) Baseline. All results are presented as means ± SD. Mean values were compared using the
paired or unpaired student t test. To compare the prevalence of micro- and macrovascular
complications or medical treatment in patients with and without HT on basis of HBP or CBP
(3), Fisher's exact test with two-tailed P values was used, and then hazard ratio and 95%
confidence intervals were calculatein.
End-points and outcome measures. Differences in outcomes for each end-point of death, and
micro- and macrovascular complications 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 factor assessment for outcomes. Risk factors determined to be statistically related to
outcomes were assessed by Cox proportional hazard analysis.
Analysis was performed using the Prism version software (GraphPad Software, CA, USA) and the
Statistical Package for the Bioscience (ComWorks Co,Tokyo,Japan). Two-tailed values of
P<0.05 were considered statistically significant.
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