Type 2 diabetes Type 2 diabetes, muscle sympathetic nerve activity
Conditions
Interventions
Oral administration of 1000 mg of imeglimin hydrochloride twice daily.
Administration period is 16 weeks
C575881
Sponsors
Takamura Masayuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spike frequency (spikes/miunte) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Contacts
Public ContactSoichiro Usui
Department of Cardiovascular Medicine, Kanazaw a University Graduate School of Medical Sciences Kanazawa University Hospital
Outcome results
None listed