Unique ID issued by UMIN | UMIN000024426 |
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Receipt number | R000028113 |
Scientific Title | Effect of dipeptidyl peptidase 4 inhibitors on Glomerulotubular regulation of sodium balance and circadian blood pressure rhythm. |
Date of disclosure of the study information | 2016/10/16 |
Last modified on | 2016/10/16 11:36:21 |
Effect of dipeptidyl peptidase 4 inhibitors on Glomerulotubular regulation of sodium balance and circadian blood pressure rhythm.
Na balance and BP rhythm during the treatment with DPP4 inhibitor.
Effect of dipeptidyl peptidase 4 inhibitors on Glomerulotubular regulation of sodium balance and circadian blood pressure rhythm.
Na balance and BP rhythm during the treatment with DPP4 inhibitor.
Japan |
Type 2 diabetic nephrology
Nephrology |
Others
NO
To investigate whether DPP-4 (dipeptidyl peptidase 4) inhibitor can restore BP rhythm from non-dipper to dipper pattern, similar to that achieved with ARB and diuretics, and whether the effect differs between 2 DPP-4 inhibitors, Linagliptin and Teneligliptin.
Efficacy
Exploratory
Pragmatic
Not applicable
Decrease in night/day ratio of blood pressure during 8 week treatment with DPP4 inhibitors (week 8)
1) increase in daytime urinary sodium excretion (day2)
2) decrease in glomerulotubular Na balance (SNa x GFR, tNa)
3) constancy of daily urinary Na excretion
4) sympathetic and parasympathetic nerve activity (assessed by heart rate variability)
5) HbA1c
6) urine anion gap, serum bicarbonate concentration
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
oral administration of Linagliptin (5mg/day) once in the morning
oral administration of Teneligliptin
(20mg/day) once in the morning
20 | years-old | <= |
Not applicable |
Male and Female
1) type 2 diabetes mellitus
2) age 20 or more years, regardless of gender
3) outpatient and inpatient
4) target HbA1c <7.0% is not achieved after approximately 3 months treatment with metformin
5) documented informed consent
1) GFR <30 30ml/min/1.73m2 or undergoing renal replacement therapy
2) severe ketosis, diabetic coma or pre-come
3) conditions with serious infection, perioperative period, and severe trauma
4) presence/possibility for pregnancy/lactation
5) GOT >100, or GPT >85
6) current treatment with insulin
7) any reason for ineligibility suggested by the attending doctor
(history of allergic reaction to study medication)
60
1st name | |
Middle name | |
Last name | Michio FUKUDA |
Nagoya City University Hospital
Division of Nephrology
1 Kawasumi, Mizuho-ku, Nasgoya 467-8601, Japan
81-52-853-8221
m-fukuda@med.nagoya-cu.ac.jp
1st name | |
Middle name | |
Last name | Miyoko Suzuki |
Nagoya City University Hospital
Clinical Research Management Center
1 Kawasumi, Mizuho-ku, Nasgoya 467-8602, Japan
81-52-858-7215
http://www.med.nagoya-cu.ac.jp/cr.dir/index.html
clinical_research@med.nagoya-cu.ac.jp
Nagoya City University Graduate School of Medical Sciences
Department of Cardio-Renal Medicine and Hypertension
none
Self funding
Nagoya City East Medical Center
Asahi Rousai Hospital
none
NO
名古屋市立大学病院(愛知県)
2016 | Year | 10 | Month | 16 | Day |
Unpublished
Enrolling by invitation
2016 | Year | 10 | Month | 11 | Day |
2016 | Year | 10 | Month | 11 | Day |
2019 | Year | 10 | Month | 10 | Day |
2019 | Year | 12 | Month | 31 | Day |
2020 | Year | 01 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2016 | Year | 10 | Month | 16 | Day |
2016 | Year | 10 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028113
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