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Effect of Imeglimin on muscle sympathetic nerve activiy in type 2 diabetes mellitus patients

Effect of Imeglimin on muscle sympathetic nerve activiy in type 2 diabetes mellitus patients

Takamura Masayuki

Department of Cardiovascular Medicine, Kanazaw a University Graduate School of Medical Sciences Kanazawa University Hospital

13-1 Takaramachi, Kanazawa City, Ishikawa Prefecture

masayuki.takamura@gmail.com

Usui Soichiro

Department of Cardiovascular Medicine, Kanazaw a University Graduate School of Medical Sciences Kanazawa University Hospital

13-1 Takaramachi, Kanazawa City, Ishikawa Prefecture

+81-76-265-2000

usuiso@m-kanazawa.jp

Recruiting

May. 28, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

basic science

1) Age 20 to 80 years old
2) Patients diagnosed with type 2 diabetes
3) HbA1c> 7% and <10% patients
4) Patients who received sufficient explanation before participating in this study, and who obtained the patient's free will to consent to the document after sufficient understanding.

1) Patients with a history of stroke or vascular replacement surgery
2) Patients who develop myocardial infarction within 3 months
3) Patients with acute coronary syndrome
4) Patients receiving drug therapy for serious lung diseases such as interstitial pneumonia
5) Patients with organic heart disease such as severe valvular disease and shunt disease
6) Patients with moderate renal dysfunction (eGFR<45 ml / min / 1.73 m2) or hepatic dysfunction (PT activity <80%)
7) Patients suspected of being involved in secondary diabetes (endocrine, drug-induced, cirrhosis, e
tc.)
8) Compromised patients such as immunocompromised patients
9) Patients with a history or complication of ketoacidosis, diabetic coma or precoma
10) Patients with a history of severe hypoglycemic symptoms with coma or loss of consciousness, or
patients with hypoglycemic symptoms (more than twice a week) in the last 8 weeks
11) Patients suspected of alcohol or substance abuse
12) Pregnant or potentially pregnant patients, or lactating patients
13) Patients being treated for malignant tumors
14) Patients with a history of hypersensitivity to imeglimin hydrochloride
15) Patients participating in other clinical trials
16) Other patients who are judged by the investigator (sharing) to be inappropriate as subjects

Both

Type 2 diabetes

Oral administration of 1000 mg of imeglimin hydrochloride twice daily.
Administration period is 16 weeks

Type 2 diabetes, muscle sympathetic nerve activity

imeglimin

D003924

C575881

Spike frequency (spikes/miunte)

Muscle sympathetic nerve activity (MSNA, Burst fre quency), baroreceptor reflex sensitivity (BRS), ech ocardiography (EF, E / e', LVDd / s, LAd), BMI, hea rt rate, heart rate variability (HRV), Blood biochem ical test, urinalysis (BNP, HbA1c, CPR, LDL-chol, TG, HDL-chol, fasting blood glucose, BUN, Cre, urin ary sugar, urinary albumin, blood catecholamine 3 fraction, urinary catecholamine 3 Fraction).

+81-76-265-2048

May. 12, 2022

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