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.
Status | Not yet recruiting |
Enrollment | 600 |
Est. completion date | April 2027 |
Est. primary completion date | March 2027 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Patients with type 2 diabetes mellitus Exclusion Criteria: - Patients with type 1 diabetes mellitus and with other diseases except diabetes mellitus |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Kyuzi Kamoi |
Kamoi K, Miyakoshi M, Soda S, Kaneko S, Nakagawa O. Usefulness of home blood pressure measurement in the morning in type 2 diabetic patients. Diabetes Care. 2002 Dec;25(12):2218-23. — View Citation
Kamoi K. Usefulness of morning home blood pressure measurements in patients with type 2 diabetes mellitus: results of a 10-year, prospective, longitudinal study. Clin Exp Hypertens. 2015;37(2):122-7. doi: 10.3109/10641963.2014.913606. Epub 2014 Apr 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Death | 20 years | Yes | |
Secondary | new, worsened, or improved microvascular and macrovascular events | 20 years | Yes |
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