UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003559 |
|---|---|
| Receipt number | R000004318 |
| Scientific Title | A prospective study on the effects of a lifestyle modification program on the urinary albumin excretion in diabetic and nondiabetic population |
| Date of disclosure of the study information | 2010/05/01 |
| Last modified on | 2012/05/01 11:53:15 |
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Basic information
Public title
A prospective study on the effects of a lifestyle modification program on the urinary albumin excretion in diabetic and nondiabetic population
Acronym
Effects of a lifestyle modification program on albuminuria
Scientific Title
A prospective study on the effects of a lifestyle modification program on the urinary albumin excretion in diabetic and nondiabetic population
Scientific Title:Acronym
Effects of a lifestyle modification program on albuminuria
Region
| Japan |
Condition
Condition
Diabetes, Metabolic syndrome,
Essential hypertension
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of a lifestyle modification program on albuminuria and to analyze its associated parameters
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reduction of urinary albumin excretion after a 12-week lifestyle modification program
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Diet education and combined aerobic and resistance exercise for 12 weeks
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
| 20 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diabetic and nondiabetic adults with informed consent for the lifestyle modification program at Niigata Institute for Health and Sports Medicine, Niigata, Japan
Key exclusion criteria
The individuals who do not consent the study, who are pregnant, who show
uncontrolled hypertension
(Blood pressure >179/109mmHg),
hyperglycemia (fasting plasma glucose > 249mg/dl) and other medical
problems
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiko Saito, M.D, Ph.D. |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Applied Molecular Medicine
Zip code
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata, 951-8510, Japan
TEL
025-227-0915
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Yamamoto, M.D. |
Organization
Niigata City General Hospital
Division name
Division of Nephrology and Rheumatology
Zip code
Address
463-7 Shumoku,Chuo-ku,Niigata, 950-1197, Japan
TEL
Homepage URL
khdy54310@smile.odn.ne.jp
Sponsor or person
Institute
Department of Applied Molecular Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
None
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
新潟県健康づくり・スポーツ医科学センター (Niigata Institute for Health and Sports Medicine)(Niigata)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2005 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 01 | Day |
Last modified on
| 2012 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004318
