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

JRCT ID: jRCT1041220023

Registered date:28/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 28/05/2022
• Target sample size: 30
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Spike frequency (spikes/miunte)
• Secondary Outcome: 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).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Takamura Masayuki