Buyuan-zhixiao Formula in the Treatment of Elderly Patients With Diabetes and Multiple Metabolic Disorders

Aging Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06358118
• Other study ID #: 2024-003-KY
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 6, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: June 2024
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Qing Ni, postgraduate
• Phone: 13701253942
• Email: 1831479145[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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;

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Diabete Mellitus
• Diabetes Mellitus
• Metabolic Diseases
• Metabolic Disorders
• Randomized Controlled Trial
• Traditional Chinese Medicine

Intervention

Drug:
• Buyuan Zhixiao Formula
Buyuan Zhixiao Formula
• Placebo
The placebo contains 10% of the active ingredients of the Chinese medicine group

Locations

Country	Name	City	State
China	China Academy of Chinese Medical Sciences Guang'anmen Hospital	Beijin	Beijing
China	Cangzhou integrative medicine hospital	Hebei
China	Hohhot Mongolian Traditional Chinese Medicine Hospital	Neimeng
China	Binzhou Traditional Chinese Medicine Hospital	Shandong
China	Yantai Baishi Traditional Chinese Medicine Hospital	Shandong
China	The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Qing Ni

Country where clinical trial is conducted

China, 

References & Publications (9)

Al Slail FY, Abid O, Assiri AM, Memish ZA, Ali MK. Cardiovascular risk profiles of adults with type-2 diabetes treated at urban hospitals in Riyadh, Saudi Arabia. J Epidemiol Glob Health. 2016 Mar;6(1):29-36. doi: 10.1016/j.jegh.2015.07.004. Epub 2015 Aug 6. — View Citation

Al-Maskari F, El-Sadig M, Nagelkerke N. Assessment of the direct medical costs of diabetes mellitus and its complications in the United Arab Emirates. BMC Public Health. 2010 Nov 8;10:679. doi: 10.1186/1471-2458-10-679. — View Citation

Carnethon MR, Biggs ML, Barzilay J, Kuller LH, Mozaffarian D, Mukamal K, Smith NL, Siscovick D. Diabetes and coronary heart disease as risk factors for mortality in older adults. Am J Med. 2010 Jun;123(6):556.e1-9. doi: 10.1016/j.amjmed.2009.11.023. — View Citation

Ji L, Hu D, Pan C, Weng J, Huo Y, Ma C, Mu Y, Hao C, Ji Q, Ran X, Su B, Zhuo H, Fox KA, Weber M, Zhang D; CCMR Advisory Board; CCMR-3B STUDY Investigators. Primacy of the 3B approach to control risk factors for cardiovascular disease in type 2 diabetes patients. Am J Med. 2013 Oct;126(10):925.e11-22. doi: 10.1016/j.amjmed.2013.02.035. Epub 2013 Jun 27. — View Citation

Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted Trends. J Epidemiol Glob Health. 2020 Mar;10(1):107-111. doi: 10.2991/jegh.k.191028.001. — View Citation

Nunes BP, Flores TR, Mielke GI, Thume E, Facchini LA. Multimorbidity and mortality in older adults: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2016 Nov-Dec;67:130-8. doi: 10.1016/j.archger.2016.07.008. Epub 2016 Aug 2. — View Citation

Quinones AR, Markwardt S, Botoseneanu A. Diabetes-Multimorbidity Combinations and Disability Among Middle-aged and Older Adults. J Gen Intern Med. 2019 Jun;34(6):944-951. doi: 10.1007/s11606-019-04896-w. Epub 2019 Feb 27. — View Citation

Ramtahal R, Khan C, Maharaj-Khan K, Nallamothu S, Hinds A, Dhanoo A, Yeh HC, Hill-Briggs F, Lazo M. Prevalence of self-reported sleep duration and sleep habits in type 2 diabetes patients in South Trinidad. J Epidemiol Glob Health. 2015 Dec;5(4 Suppl 1):S — View Citation

Sinclair A, Saeedi P, Kaundal A, Karuranga S, Malanda B, Williams R. Diabetes and global ageing among 65-99-year-old adults: Findings from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2020 Apr;162:108078. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	unit:%	Measured at 0, 3, 6, and 12 months respectively.
Secondary	Fasting blood glucose	unit:mmol/l	Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
Secondary	2-hour postprandial blood glucose	unit:mmol/l	Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
Secondary	blood pressure	unit:mmHg	Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
Secondary	weight	unit:KG	Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
Secondary	waist circumference	unit:cm	Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
Secondary	BMI	unit:kg/m2	Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
Secondary	Total Cholesterol	unit:mmol/l	Measured at 0, 3, 6, and 12 months
Secondary	Triglycerides	unit:mmol/l	Measured at 0, 3, 6, and 12 months
Secondary	High density lipoprotein cholesterol	unit:mmol/l	Measured at 0, 3, 6, and 12 months
Secondary	Low density lipoprotein cholesterol	unit:mmol/l	Measured at 0, 3, 6, and 12 months
Secondary	Ankle-Brachial Index(ABI)	The normal range for the ABI is generally considered to be from 0.9 to 1.3.	Measured at 0, 3, 6, and 12 months
Secondary	Fasting insulin	unit:pmol/L	Measured at 0, 3, 6, and 12 months
Secondary	C-peptide	unit:pmol/L	Measured at 0, 3, 6, and 12 months
Secondary	insulin resistance index		Measured at 0, 3, 6, and 12 months
Secondary	islet ß-cell function index		Measured at 0, 3, 6, and 12 months
Secondary	lipid Lipid accumulation product		Measured at 0, 3, 6, and 12 months
Secondary	visceral adiposity index		Measured at 0, 3, 6, and 12 months
Secondary	Measurement Results of Tumor Necrosis Factor-alpha Levels at Different Time Points		Measured at 0, 3, 6, and 12 months
Secondary	Concentration Variation of Interleukin-10		Measured at 0, 3, 6, and 12 months
Secondary	Change in Homocysteine Levels		Measured at 0, 3, 6, and 12 months
Secondary	Average Concentration of Interleukin-6		Measured at 0, 3, 6, and 12 months
Secondary	Change in Endothelin-1 Levels		Measured at 0, 3, 6, and 12 months
Secondary	Average Concentration of Nitric Oxide		Measured at 0, 3, 6, and 12 months
Secondary	Concentration Variation of Von Willebrand Factor		Measured at 0, 3, 6, and 12 months
Secondary	Measurement Results of Vascular Endothelial Growth Factor Levels at Different Time Points		Measured at 0, 3, 6, and 12 months
Secondary	Change in Matrix Metalloproteinase-9 Levels" or "Participants' Matrix Metalloproteinase-9 Concentration		Measured at 0, 3, 6, and 12 months
Secondary	Average Concentration of Soluble Intercellular Adhesion Molecule-1		Measured at 0, 3, 6, and 12 months
Secondary	Change in Serum Tau Protein Levels		Measured at 0, 3, 6, and 12 months
Secondary	Average Concentration of Aß40		Measured at 0, 3, 6, and 12 months
Secondary	Average Concentration of Aß42		Measured at 0, 3, 6, and 12 months
Secondary	Change in Neurofilament Light Chain Protein Levels		Measured at 0, 3, 6, and 12 months
Secondary	Carotid Ultrasound; Carotid Intima-Media Thickness.		Measured at 0, 6, and 12 months
Secondary	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
Secondary	Montreal Cognitive Assessment Score	The maximum score is 30 points, and the higher the score, the better the cognitive function.	Measured at 0, 3, 6, and 12 months
Secondary	Fried Frailty Phenotype Scale	Those who have 5 or more of the items in the table can be diagnosed as frailty syndrome; those with less than 3 items are in the early stage of frailty; 0 items are healthy elderly people without frailty.	Measured at 0, 3, 6, and 12 months
Secondary	Activities of Daily Living Scale score	The scale consists of 10 items, with a total score of 100 points. The Cronbach's alpha of the scale is 0.813. A score of 100 points is considered normal, while scores below 100 indicate a decline.A score of 100 points indicates full independence in daily living, without any dependency; 61-99 points suggest mild dependency; 41-60 points indicate moderate dependency; =40 points denote severe dependency.	Measured at 0, 3, 6, and 12 months
Secondary	Mini Nutritional Rating Scale	The total score is 14 points, with the Cronbach's alpha of the scale being 0.906. A score of =7 points is considered malnourished, 8-11 points indicate a risk of malnutrition, and 12-14 points are indicative of normal nutrition.; The total score is 14 points, with the Cronbach's alpha of the scale being 0.906. A score of =7 points is considered malnourished, 8-11 points indicate a risk of malnutrition, and 12-14 points are indicative of normal nutrition.	Measured at 0, 3, 6, and 12 months
Secondary	Serum and urine metabolomics	Inferring the potential biological mechanisms of the effect of Buyuan Zhixiao Formula based on the differences in metabolic products in the blood and urine between the experimental and control groups.	Measured at 0 and 6 months respectively