UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001886 |
|---|---|
| Receipt number | R000002250 |
| Scientific Title | A multicenter observational study of clinical relevance of microalbuminuria and intra-renal RAS in type 2 diabetes. |
| Date of disclosure of the study information | 2009/04/14 |
| Last modified on | 2016/10/28 17:25:16 |
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Basic information
Public title
A multicenter observational study of clinical relevance of microalbuminuria and intra-renal RAS in type 2 diabetes.
Acronym
Clinical relevance of diabetic complications and intra-renal RAS in type 2 diabetes.
Scientific Title
A multicenter observational study of clinical relevance of microalbuminuria and intra-renal RAS in type 2 diabetes.
Scientific Title:Acronym
Clinical relevance of diabetic complications and intra-renal RAS in type 2 diabetes.
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate urinary AGT as a predictor for diabetic nephropathy in type 2 diabetes and to compare its efficacy with that of microalbuminuria
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) AGT (urine and serum): 0, 6, 12, 18, 24, 30 and 36 months
2) Albumin (urine): 0, 6, 12, 18, 24, 30 and 36 months
Key secondary outcomes
1) BP: 0, 6, 12, 18, 24, 30 and 36 months
2) BW, BMI, waist circumference:0, 6, 12, 18, 24, 30 and 36 months
3) FBS, insulin, HbA1c: 0, 6, 12, 18, 24, 30 and 36 months
4) PRA, Aldosterone: 0, 12, 24 and 36 months
5) T-chol, LDL-chol, HDL-chol, TG: 0, 12, 24 and 36 months
6) Cr, BUN, UA: 0, 6, 12, 18, 24, 30 and 36 months
7) Transferrin, type IV collagen (urine): 0, 6, 12, 18, 24, 30 and 36 months
8) Cardiovascular events: 0-36 months
9) Insulin sensitivity: 0, 12, 24 and 36 months
10) hsCRP: 0, 12, 24 and 36 months
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Albuminuria <=30 mg/gCr
2) Diabetes mellitus
- FBS >= 126 mg/dL
- 75g OGTT (2 hours) >= 200 mg/dL
- PPG >= 200 mg/dL
3) BP <= 130/80 mmHg
4) Patients who have not been treated with ARB, ACEI or MR blocker within 4 weeks
Key exclusion criteria
1) Type 1 diabetes mellitus
2) Pregnancy
3) Severe renal disease (Proteinuria, CCr<50 mL/min, sCr >= 1.5 mg/dL)
4) Severe hepatic disease (GOT >= 150 IU or GPT >= 150 IU)
5) Endocrine disease
6) Patients with malignant tumor
7) Patients inadequate for the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Ishida |
Organization
Kagawa University, Faculty of Medicine
Division name
Division of Hematology, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-891-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Hitomi |
Organization
Kagawa University, Faculty of Medicine
Division name
Department of Pharmacology
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-891-5111
Homepage URL
hitomi@kms.ac.jp
Sponsor or person
Institute
Kagawa University, Faculty of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 04 | Month | 14 | 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
Completed
Date of protocol fixation
| 2009 | Year | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective cohort study
predictive variable:
Urinary AGT
outcome variable:
Microalbuminuria
Hypertension
Management information
Registered date
| 2009 | Year | 04 | Month | 14 | Day |
Last modified on
| 2016 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002250
