Type 2 diabetes mellitus with left ventricular diastolic dysfunction
Conditions
Interventions
T2DM with LVDD group:For patients in the T2DM combined with LVDD group, basic therapy is administered through the following measures, including patient education, dietary therapy, exercise therapy, an
Type 2 Diabetes Mellitus with Comorbid Left Ventricular Diastolic Dysfunction plus Yixiao Formula Group:Patients in the T2DM combined with LVDD plus Yixiao formula group were administered Yixiao formu
Sponsors
Beijing University of Chinese Medicine Dongzhimen Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age 30~80 years old; (2) Meet the diagnostic criteria for type 2 diabetes mellitus and have a glycated hemoglobin level =9%; (3) Meet the diagnostic criteria for impaired left ventricular diastolic function; (4) Meet the traditional Chinese medicine diagnostic criteria for qi and yin deficiency with blood stasis; (5) Be able to accurately express their own and voluntarily sign the informed consent form, agreeing to participate in the clinical trial as a subject.
Exclusion criteria
Exclusion criteria: (1) Left ventricular ejection fraction <50%; (2) Patients with Type 1 diabetes mellitus and other types of diabetes mellitus; (3) Patients with clearly diagnosed rheumatic heart valve disease, hypertrophic cardiomyopathy, and dilated cardiomyopathy, etc.; (4) Patients with acute or severe complications of diabetes, such as ketoacidosis, hyperosmolar coma, and infection; (5) Patients with chronic wasting diseases, such as immune system diseases and malignant tumors; (6) Patients with severe renal failure and hepatic coma, or patients with renal insufficiency requiring hemodialysis; (7) Patients with severe electrolyte disorders and hematological diseases; (8) Patients with various mental disorders; (9) Pregnant or breastfeeding women, women planning pregnancy, or women without contraceptive plans; (10) Patients with diabetic retinopathy (proliferative stage) or bleeding disorders; (11) Patients with known allergy to the drugs used in this study; (12) Patients who have participated in other clinical trials within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiac structural indices: left ventricular end-diastolic diameter( LVEDD), left ventricular posterior wall thickness (LVPWT), interventricular septal thickness (IVST), left ventricular end-diastolic volume (LVEDV), left ventricular mass index (LVMI), left atrial anterior-posterior diameter (LAAPd), left atrial left-right diameter (LALRd), and left atrial superior-inferior diameter (LASId). LVMI is derived by dividing left ventricular mass ( LVM) by individual body surface area (BSA), where LVM = 0.81 × 1.04 × [(IVST + LVPWT + LVEDD)³ - LVEDD³] + 0.6, and BSA = 0.0061 × height (cm) + 0.0128 × weight (kg) - 0.1529.;Cardiac function indicators: Mitral valve orifice blood flow Doppler early diastolic E peak (E), late diastolic A peak (A), E/A, mitral annulus tissue Doppler early diastolic e' peak (septal e', lateral e'), E/e' (Avg), tricuspid regurgitation velocity (TRV), left atrial volume index (LAVI), LVEF, and LVFS.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sugar metabolism indicators: fasting blood glucose FBG), postprandial 2-hour blood glucose (2hPG), glycated serum albumin (GA), glycated hemoglobin (HbA1c).; | — |
Countries
China
Contacts
Public ContactXiaohui Yang
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Outcome results
None listed