NCT06358118尚未招募不适用
Clinical Research on Evidence Based Traditional Chinese Medicine for Elderly Diabetes Based on State Target Theory-Buyuan Zhixiao Fang in the Treatment of Elderly Patients With Diabetes and Multiple Metabolic Disorders: Study Protocol for a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Qing Ni6 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年7月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 6
- 主要终点
- HbA1c
研究概览
简要总结
The primary objective of this clinical trial is to assess the clinical efficacy and safety of the Buyuan Zhixiao Formula in treating elderly patients with diabetes and multiple metabolic disorders exhibiting symptoms of renal deficiency and blood stasis. Furthermore, this study aims to intervene in high-risk factors to prevent arteriosclerosis and to investigate the clinical efficacy of the Buyuan Zhixiao Formula in the prevention and treatment of cognitive impairments.
The main questions it aims to answer are:
- What are the clinical effects of Buyuan Zhixiao Formula, including lowering blood sugar, lowering blood pressure, lowering lipids, and treating obesity?
- Can Buyuan Zhixiao Formula improve cognitive impairment in diabetes? Researchers compared Buyuan Zhixiao Formula with a placebo (a drug that looks similar but contains only 10% of the active ingredients) to see if the drug Buyuan Zhixiao Formula can treat elderly people with diabetes and multiple metabolic disorders.
Participants will:
- Take the drug Bu Yuan Zhi XiaoFormula or placebo every day for 6 months；Follow-up for 6 months；
- Check fasting blood sugar and 2-hour postprandial blood sugar every month; check HbA1c, blood lipids, vascular function, and cognitive impairment serum markers every 3 months;
- Conduct scores on TCM symptoms, cognitive ability, nutritional status and other scales and adverse events;
- Urine and serum samples were collected before and after treatment;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age ≥65 years, irrespective of sex;
- •2.Individuals who meet the Western medical diagnostic criteria for type 2 diabetes mellitus (T2DM) in the elderly, with a hemoglobin A1c level of ≥7.0% in the past three months;
- •3.Compliance with the diagnostic criteria for abdominal obesity (waist circumference ≥90 cm for males and ≥85 cm for females);
- •4.Conformity to the diagnostic standards for hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg);
- •5.A history of dyslipidemia, where lipid levels have not reached the general control standards for elderly individuals with T2DM following oral lipid-lowering therapy (statins/bile acid sequestrants): LDL cholesterol <2.6 mmol/L and/or triglycerides <2.5 mmol/L;
- •6.Diagnosis of kidney deficiency and blood stasis according to traditional Chinese medicine, with the pattern type referring to the《Guidelines for Clinical Research of New Chinese Medicines》;
- •7.Willingness to sign an informed consent document.
排除标准
- •1.Exclusion of individuals who, within the past week, have experienced severe infections, acute cardiovascular or cerebrovascular events (such as acute cerebral infarction or myocardial infarction), significant trauma, acute pancreatitis, or other conditions that could precipitate stress-induced hyperglycemia. This also extends to those with concurrent endocrinopathies that may induce insulin resistance, such as Cushing's syndrome, hyperthyroidism, or pituitary growth hormone adenomas, as well as those currently receiving treatment with glucocorticoids or undergoing chemotherapy for malignancies.
- •2.Exclusion of individuals with a history of neurological disorders or psychiatric conditions that could impair cognitive function, as well as those with a history of medication use for these conditions.
- •3.Exclusion of individuals with severe complications of diabetes such as diabetic nephropathy in the uremic stage, or those with significant primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems, as well as individuals diagnosed with cancer.
- •4.Exclusion of individuals with communication barriers that could affect the assessment of cognitive function, including severe impairments in speech, vision, and hearing.
- •5.Individuals who have participated in other pharmacological clinical trials within the past month.
- •6.Individuals who have insufficient understanding of this study, are unwilling to participate, or, based on the researchers' judgment, present a reduced likelihood of enrollment or poor compliance due to unstable work and living locations or other factors that could lead to loss to follow-up.
研究组 & 干预措施
experimental group
Experimental
Take Buyuan Zhixiao Formula granules
干预措施: Buyuan Zhixiao Formula (Drug)
control group
Placebo Comparator
Take a placebos
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c
时间窗: Measured at 0, 3, 6, and 12 months respectively.
unit：%
次要结局
- Triglycerides(Measured at 0, 3, 6, and 12 months)
- BMI(Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively)
- 2-hour postprandial blood glucose(Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively)
- weight(Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively)
- waist circumference(Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively)
- Fasting blood glucose(Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively)
- blood pressure(Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively)
- Average Concentration of Interleukin-6(Measured at 0, 3, 6, and 12 months)
- Concentration Variation of Von Willebrand Factor(Measured at 0, 3, 6, and 12 months)
- Average Concentration of Soluble Intercellular Adhesion Molecule-1(Measured at 0, 3, 6, and 12 months)
- Change in Serum Tau Protein Levels(Measured at 0, 3, 6, and 12 months)
- Activities of Daily Living Scale score(Measured at 0, 3, 6, and 12 months)
- Serum and urine metabolomics(Measured at 0 and 6 months respectively)
- islet β-cell function index(Measured at 0, 3, 6, and 12 months)
- visceral adiposity index(Measured at 0, 3, 6, and 12 months)
- Measurement Results of Tumor Necrosis Factor-alpha Levels at Different Time Points(Measured at 0, 3, 6, and 12 months)
- Total Cholesterol(Measured at 0, 3, 6, and 12 months)
- Low density lipoprotein cholesterol(Measured at 0, 3, 6, and 12 months)
- lipid Lipid accumulation product(Measured at 0, 3, 6, and 12 months)
- Concentration Variation of Interleukin-10(Measured at 0, 3, 6, and 12 months)
- Change in Homocysteine Levels(Measured at 0, 3, 6, and 12 months)
- Average Concentration of Aβ42(Measured at 0, 3, 6, and 12 months)
- Change in Neurofilament Light Chain Protein Levels(Measured at 0, 3, 6, and 12 months)
- Montreal Cognitive Assessment Score(Measured at 0, 3, 6, and 12 months)
- Fried Frailty Phenotype Scale(Measured at 0, 3, 6, and 12 months)
- Mini Nutritional Rating Scale(Measured at 0, 3, 6, and 12 months)
- Ankle-Brachial Index（ABI）(Measured at 0, 3, 6, and 12 months)
- Fasting insulin(Measured at 0, 3, 6, and 12 months)
- Change in Matrix Metalloproteinase-9 Levels" or "Participants' Matrix Metalloproteinase-9 Concentration(Measured at 0, 3, 6, and 12 months)
- Average Concentration of Aβ40(Measured at 0, 3, 6, and 12 months)
- High density lipoprotein cholesterol(Measured at 0, 3, 6, and 12 months)
- C-peptide(Measured at 0, 3, 6, and 12 months)
- insulin resistance index(Measured at 0, 3, 6, and 12 months)
- Change in Endothelin-1 Levels(Measured at 0, 3, 6, and 12 months)
- Average Concentration of Nitric Oxide(Measured at 0, 3, 6, and 12 months)
- Measurement Results of Vascular Endothelial Growth Factor Levels at Different Time Points(Measured at 0, 3, 6, and 12 months)
- Carotid Ultrasound; Carotid Intima-Media Thickness.(Measured at 0, 6, and 12 months)
- Activities of Daily Living Scale score; Fried Frailty Phenotype Scale; Mini Nutritional Rating Scale; MoCA scale score; Traditional Chinese Medicine Kidney Deficiency and Blood Stasis Syndrome Scale score.(Measured at 0, 3, 6, and 12 months)
研究者
Qing Ni
Clinical Professor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
研究点 (6)
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