Unique ID issued by UMIN | UMIN000001887 |
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Receipt number | R000002268 |
Scientific Title | A prospective, time-series, multicenter study on the effect of telmisartan on intra-renal RAS in type 2 diabetes. |
Date of disclosure of the study information | 2009/04/14 |
Last modified on | 2016/10/28 17:27:37 |
A prospective, time-series, multicenter study on the effect of telmisartan on intra-renal RAS in type 2 diabetes.
Effect of telmisartan on intra-renal RAS in type 2 diabetes
A prospective, time-series, multicenter study on the effect of telmisartan on intra-renal RAS in type 2 diabetes.
Effect of telmisartan on intra-renal RAS in type 2 diabetes
Japan |
Type 2 Diabetes Mellitus
Cardiology | Endocrinology and Metabolism | Nephrology |
Others
NO
To evaluate the effect of telmisartan on urinary AGT in type 2 diabetes patients
To clarify whether urinary AGT levels serve as a predictor for organ protection by ARB in type 2 diabetes patients
Efficacy
Exploratory
Pragmatic
Phase IV
1) AGT (urine and serum): 0, 6 and 12 months
2) Albumin (urine): 0, 6 and 12 months
1) BP: 0, 2, 4, 6, 8, 10 and 12 months
2) BW, BMI, waist circumference:0, 6 and 12 months
3) FBS, insulin, HbA1c: 0, 6 and 12 months
4) PRA, Aldosterone: 0 and 12 months
5) T-chol, LDL-chol, HDL-chol, TG: 0 and 12 months
6) Cr, BUN, UA: 0, 6 and 12 months
7) Cardiovascular events: 0-12 months
8) Insulin sensitivity: 0, 6 and 12 months
9) hsCRP: 0, 6 and 12 months
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Telmisartan (20-80 mg/day, 12 months)
20 | years-old | <= |
75 | years-old | > |
Male and Female
1) Diabetes mellitus
- FBS >= 126 mg/dL
- 75g OGTT (2 hours) >= 200 mg/dL
- PPG >= 200 mg/dL
2) Patients who have not been treated with an anti-hypertensive drug within 4 weeks
1) Type 1 diabetes mellitus
2) Pregnancy
3) Severe renal disease (CCr<30 mL/min, sCr >= 2.0 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
160
1st name | |
Middle name | |
Last name | Toshihiko Ishida |
Kagawa University, Faculty of Medicine
Division of Hematology, Endocrinology and Metabolism, Department of Internal Medicine
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
087-891-5111
1st name | |
Middle name | |
Last name | Hirofumi Hitomi |
Kagawa University, Faculty of Medicine
Department of Pharmacology
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
087-891-5111
hitomi@kms.ac.jp
Kagawa University, Faculty of Medicine
None
Self funding
NO
2009 | Year | 04 | Month | 14 | Day |
Unpublished
Completed
2009 | Year | 02 | Month | 26 | Day |
2009 | Year | 04 | Month | 01 | Day |
2013 | Year | 06 | Month | 01 | Day |
2009 | Year | 04 | Month | 14 | Day |
2016 | Year | 10 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002268
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