Clinical trial NCT06358118: Buyuan-zhixiao Formula in the Treatment of Elderly Patients With Diabetes and Multiple Metabolic Disorders
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabete Mellitus
Aging
Metabolic Disorders
Traditional Chinese Medicine
Randomized Controlled Trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 240
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

1. What are the clinical effects of Buyuan Zhixiao Formula, including lowering blood sugar, lowering blood pressure, lowering lipids, and treating obesity?
2. 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:

1. Take the drug Bu Yuan Zhi XiaoFormula or placebo every day for 6 months；Follow-up for 6 months；
2. 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;
3. Conduct scores on TCM symptoms, cognitive ability, nutritional status and other scales and adverse events;
4. Urine and serum samples were collected before and after treatment;


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: HbA1c
timeFrame: Measured at 0, 3, 6, and 12 months respectively.
Secondary outcomes:
measure: Fasting blood glucose
timeFrame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
measure: 2-hour postprandial blood glucose
timeFrame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
measure: blood pressure
timeFrame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
measure: weight
timeFrame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
measure: waist circumference
timeFrame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
measure: BMI
timeFrame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
measure: Total Cholesterol
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Triglycerides
timeFrame: Measured at 0, 3, 6, and 12 months
measure: High density lipoprotein cholesterol
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Low density lipoprotein cholesterol
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Ankle-Brachial Index（ABI）
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Fasting insulin
timeFrame: Measured at 0, 3, 6, and 12 months
measure: C-peptide
timeFrame: Measured at 0, 3, 6, and 12 months
measure: insulin resistance index
timeFrame: Measured at 0, 3, 6, and 12 months
measure: islet β-cell function index
timeFrame: Measured at 0, 3, 6, and 12 months
measure: lipid Lipid accumulation product
timeFrame: Measured at 0, 3, 6, and 12 months
measure: visceral adiposity index
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Measurement Results of Tumor Necrosis Factor-alpha Levels at Different Time Points
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Concentration Variation of Interleukin-10
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Change in Homocysteine Levels
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Average Concentration of Interleukin-6
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Change in Endothelin-1 Levels
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Average Concentration of Nitric Oxide
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Concentration Variation of Von Willebrand Factor
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Measurement Results of Vascular Endothelial Growth Factor Levels at Different Time Points
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Change in Matrix Metalloproteinase-9 Levels" or "Participants' Matrix Metalloproteinase-9 Concentration
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Average Concentration of Soluble Intercellular Adhesion Molecule-1
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Change in Serum Tau Protein Levels
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Average Concentration of Aβ40
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Average Concentration of Aβ42
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Change in Neurofilament Light Chain Protein Levels
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Carotid Ultrasound; Carotid Intima-Media Thickness.
timeFrame: Measured at 0, 6, and 12 months
measure: 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.
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Montreal Cognitive Assessment Score
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Fried Frailty Phenotype Scale
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Activities of Daily Living Scale score
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Mini Nutritional Rating Scale
timeFrame: Measured at 0, 3, 6, and 12 months
measure: Serum and urine metabolomics
timeFrame: Measured at 0 and 6 months respectively
Other outcomes:
Locations:
city: Beijin
country: China
facility: China Academy of Chinese Medical Sciences Guang'anmen Hospital
state: Beijing
city: Hebei
country: China
facility: Cangzhou integrative medicine hospital
city: Neimeng
country: China
facility: Hohhot Mongolian Traditional Chinese Medicine Hospital
city: Shandong
country: China
facility: Binzhou Traditional Chinese Medicine Hospital
city: Shandong
country: China
facility: Yantai Baishi Traditional Chinese Medicine Hospital
city: Tianjin
country: China
facility: The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Study officials:
affiliation: China Academy of Chinese Medical Sciences Guang'anmen Hospital
name: Qing Ni, postgraduate
role: PRINCIPAL_INVESTIGATOR
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