The study for association between peripheral vasoconstrictor response and myocardial diastolic dysfunction in patients with type 2 diabetes

UMIN ID: UMIN000055459

Registered date:09/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 2024/09/07
• Target sample size: 78
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Correlation between index of myocardial diastolic dysfunction and peripheral vasoconstrictor response.
• Secondary Outcome: Correlation of diabetic neuropathy parameters (CVR-R, Schellong test, nerve conduction velocity test, etc.) with myocardial diastolic dysfunction and other cardiac function parameters (BNP, left ventricular ejection fraction, fQRS, etc.). Correlation of cardiac function parameters with clinical indicators of diabetic complications (retinopathy stage, urinary albumin, eGFR, etc.). Blood test: NT-proBNP, high-sensitivity CRP, TNF-alpha, IL-6, total PAI-1, Renin, Aldosterone, Adrenaline, Noradrenaline, Dopamine, Eotaxin, HMW (high molecular weight)-adiponectin, MLC (myosin light chain)-1, etc. Vascular endothelial function test: End-PAT Peripheral vasoconstriction response: laser doppler flowmetry Electrocardiography: fQRS, CVR-R, etc. Evaluation of peripheral arterial disease: ABI (ankle brachial index) Echocardiography: GLS, E/e, E/A, DcT, etc.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients with type 1 diabetes, or diabetes caused by other specific mechanistic diseases 2) Patients with diabetes during pregnancy 3) Patients hospitalized due to acute complications of diabetes (DKA, HHS, hypoglycemia, etc.) 4) Patients hospitalized for acute infectious diseases (pneumonia, cellulitis, etc.) 5) Patients hospitalized for cardiovascular diseases (ACS, Af, etc.) 6) Patients with a history of catheterization for cardiovascular diseases within 1 year 7) Patients with a left ventricular ejection fraction (EF) of 40% or less 8) Patients with heart failure symptoms or anginal pain in the resting state 9) Patients on oral beta-blockers 10) Patients with an ABI (ankle brachial pressure index) of less than 0.9 11) Patients with severe hepatic dysfunction 12) Patients with neurological disease presenting with autonomic neuropathy

Related Information

• Primary Sponsor: Department of Endocrinology and Metabolism, Dokkyo Medical University
• Source(s) of Monetary Support: Dokkyo Medical University