UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003437 |
|---|---|
| Receipt number | R000004164 |
| Scientific Title | Effect of telmisartan on insulin resistance with hypertensive patients older than 65 years old. |
| Date of disclosure of the study information | 2010/04/30 |
| Last modified on | 2010/04/02 15:08:25 |
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Basic information
Public title
Effect of telmisartan on insulin resistance with hypertensive patients older than 65 years old.
Acronym
Insulin resistance in elderly subjects
Scientific Title
Effect of telmisartan on insulin resistance with hypertensive patients older than 65 years old.
Scientific Title:Acronym
Insulin resistance in elderly subjects
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine blood pressure reduction and insulin resistance in elderly patients with metabolic syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The following examinations will be carried out at 1, 3, 6, 12 months.
1)home blood pressure
2)serum insulin
3)bloo glucose
4)HbA1c
5)LDL cholesterol
6)urinary excretion of albumin/creatine
Key secondary outcomes
The following examinations will be carried out at 1, 3, 6, 12 months.
1)serum creatinine
2)serum potassim
3)eGFR
4)BMI
5)girth of the abdomen
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with hypertension older than 65 years old
Key exclusion criteria
eGFR<45mL/min/1.73m2
hyperkalemia more than 5.0mEq/L
diabetes mellitus
younger than 65 years old
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromichi Suzuki |
Organization
Saitama Medical University
Division name
Department of Nephrology
Zip code
Address
38 Morohonngo, Moroyamamachi, Irumagun, 350-0495, Saitama, Japan
TEL
+81-49-276-1620
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromichi Suzuki |
Organization
Saitama Medical University
Division name
Department of Nephrology
Zip code
Address
38 Morohonngo, Moroyamamachi, Irumagun, 350-0495, Saitama, Japan
TEL
+81-49-276-1620
Homepage URL
Sponsor or person
Institute
Department of Nephrology
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Non profit organization Saitam Health Promotion Network
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
埼玉医科大学病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2009 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 01 | Day |
Other
Other related information
Telmisartan will produce reduction of insulin resitance accompanied with blood pressure reduction.
Management information
Registered date
| 2010 | Year | 04 | Month | 02 | Day |
Last modified on
| 2010 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004164
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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