Ignite Creation Date:
2024-05-06 @ 7:34 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02569151
Status:
NOT_YET_RECRUITING
Last Update Posted:
2015-10-06
First Post:
2015-10-05
Brief Title:
20 Years Results by HBP and DBP in Patients With Type 2 Diabetes Mellitus After Following-up
Sponsor:
Kyuzi Kamoi
Organization:
Nagaoka Red Cross Hospital
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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 Fishers 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
Clinic hypertension CH and morning hypertension MH were defined as systolic BP SBP 130 mmHg andor 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 Fishers 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
Detailed Description:
Microalbuminuria and clinical albuminuria were defined as urinary albumin excretion rate 30 mgg creatinine and 300 mgg 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 andor 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 andor 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 Fishers 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 CoTokyoJapan Two-tailed values of P005 were considered statistically significant
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 andor 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 andor 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 Fishers 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 CoTokyoJapan Two-tailed values of P005 were considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None