UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter observational study of clinical relevance of microalbuminuria and intra-renal RAS in type 2 diabetes.
Title of the study (Brief title)	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	Toshihiko Ishida
Organization	Kagawa University, Faculty of Medicine
Division name	Division of Hematology, Endocrinology and Metabolism, Department of Internal Medicine
Address	1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL	087-891-5111
Email

Public contact
Name of contact person	Hirofumi Hitomi
Organization	Kagawa University, Faculty of Medicine
Division name	Department of Pharmacology
Address	1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL	087-891-5111
Homepage URL
Email	hitomi@kms.ac.jp

Sponsor
Institute	Kagawa University, Faculty of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 02 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002250