Multiple Metabolic Disorders in Elderly Patients with Diabetes Mellitus
Conditions
Interventions
Experimental Group:Jinqi Jiangtang Tablets, 3 tablets per dose, 3 times a day, taken with warm water.
Control Group:Placebo, 3 tablets per dose, 3 times a day, taken with warm water.
Sponsors
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >= 65 years old, regardless of gender; 2.With a past or newly diagnosed history of Type 2 Diabetes Mellitus (T2DM), and no prior treatment with Western medicine; 3.Glycated Hemoglobin A1c (HbA1c) ranging from 6.5% to 10.5% (inclusive); 4.With a past or newly diagnosed history of hypertension; 5.With a past or newly diagnosed history of hyperlipidemia; and Low-Density Lipoprotein Cholesterol (LDL-C) > 1.8 mmol/L and/or Triglycerides (TG) > 1.7 mmol/L; 6.TCM syndrome differentiation belongs to the syndrome of qi deficiency and internal heat, with clinical manifestations including thirst with a preference for drinking, easy hunger and polyphagia, and shortness of breath with fatigue; 7.Those who voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Elderly T2DM patients with poor comprehensive health status, including those with end-stage chronic diseases, moderate to severe dementia, long-term care needs, or impairment in >= 2 basic activities of daily living (BADL); 2.Patients with a history of Atherosclerotic Cardiovascular Disease (ASCVD), such as cerebral infarction, myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or cardiac pacemaker implantation; or patients with heart failure classified as New York Heart Association (NYHA) Class III or IV; 3.Patients with a history of fourth lumbar vertebra fracture or post-fracture surgery; 4.Patients with a history of thyroid dysfunction, or a history of thyroid or parathyroid gland resection surgery; 5.Patients with various acute infections, severe infections, severe anemia, neutropenia, or a history of coagulation disorders (e.g., hemophilia, von Willebrand disease, sickle cell anemia); 6.Patients with severe diseases of the heart, brain, kidneys, hematopoietic system, etc., including: acute cerebrovascular diseases or combined central nervous system dysfunction; patients unable to take care of themselves due to coronary artery intervention (e.g., percutaneous transluminal coronary angioplasty [PTCA] or CABG) or stroke; diabetic nephropathy (glomerular filtration rate 300 mg/g); severe liver dysfunction (alanine aminotransferase [ALT] > 3 times the upper limit of normal); or other major diseases such as active or untreated malignant tumors; 7.Patients who have participated in other drug clinical trials within the past month; 8.Patients who have insufficient understanding of this study or are unwilling to participate; or patients deemed by researchers to have reduced enrollment possibility or poor compliance, such as unstable work or living locations that may lead to loss of follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin compliance rate;Blood Lipids; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose;Postprandial Blood Glucose;Glycated Hemoglobin;Total Cholesterol;Low-Density Lipoprotein;High-Density Lipoprotein;Triglycerides;Fasting Insulin;Insulin Resistance Index;C-Peptide;Electrocardiogram data;B-type Natriuretic Peptide;Framingham Risk Score;ASCVD (Atherosclerotic Cardiovascular Disease) Risk Score;Blood Pressure;Alanine Aminotransferas;Aspartate Aminotransferase;Gamma-glutamyl Transferase;Total Bilirubin;Albumin;Serum Creatinine;Blood Urea Nitrogen;Uric Acid;Glomerular Filtration Rate; | — |
Countries
China
Contacts
Public ContactLei Ye
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Outcome results
None listed