Diabete MellitusNCT06358118
Buyuan-zhixiao Formula in the Treatment of Elderly Patients With Diabetes and Multiple Metabolic Disorders
A study testing Buyuan Zhixiao Formula in people with Diabete Mellitus and Aging, run by Qing Ni at 6 sites in China.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabete Mellitus, Aging, Metabolic Disorders
- What is being tested?
- Buyuan Zhixiao Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 6 sitesChina
- Study dates
- 6 Jul 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
China Academy of Chinese Medical Sciences Guang'anmen Hospital
Beijin, Beijing Municipality, 100053
Qing Ni, postgraduate, 010-88001245, 1831479145@qq.com
zhige Wen, postgraduate, 15890643963, 1831479145@qq.com
Cangzhou integrative medicine hospital
Hebei
zhongyong zhang, postgraduate, 18031783396, zzyhappy666@126.com
Hohhot Mongolian Traditional Chinese Medicine Hospital
Neimeng
Binzhou Traditional Chinese Medicine Hospital
Shandong
lijuan Du, postgraduate, 18800102622, 137425497@qq.com
Yantai Baishi Traditional Chinese Medicine Hospital
Shandong
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin
bin Wang, postgraduate, 13051395068
About this study
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
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:
Read more
- 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;
- Conditions
- Diabete Mellitus, Aging, Metabolic Disorders, Traditional Chinese Medicine, Randomized Controlled Trial
- Being tested
- Buyuan Zhixiao Formula, Placebo
- Medical subject headings
- Diabetes Mellitus, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buyuan Zhixiao FormulaDrug
Buyuan Zhixiao Formula
PlaceboDrug
The placebo contains 10% of the active ingredients of the Chinese medicine group
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Take Buyuan Zhixiao Formula granules Receives: Drug: Buyuan Zhixiao Formula |
| control group | Placebo comparator | Take a placebos Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
unit：%
Measured: Measured at 0, 3, 6, and 12 months respectively.
Secondary outcomes (38)
Fasting blood glucose
unit：mmol/l
Measured: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
2-hour postprandial blood glucose
unit：mmol/l
Measured: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
blood pressure
unit：mmHg
Measured: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
weight
unit：KG
Measured: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
waist circumference
unit：cm
Measured: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
BMI
unit：kg/m2
Measured: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
Total Cholesterol
unit：mmol/l
Measured: Measured at 0, 3, 6, and 12 months
Triglycerides
unit：mmol/l
Measured: Measured at 0, 3, 6, and 12 months
High density lipoprotein cholesterol
unit：mmol/l
Measured: Measured at 0, 3, 6, and 12 months
Low density lipoprotein cholesterol
unit：mmol/l
Measured: Measured at 0, 3, 6, and 12 months
Ankle-Brachial Index（ABI）
The normal range for the ABI is generally considered to be from 0.9 to 1.3.
Measured: Measured at 0, 3, 6, and 12 months
Fasting insulin
unit：pmol/L
Measured: Measured at 0, 3, 6, and 12 months
C-peptide
unit：pmol/L
Measured: Measured at 0, 3, 6, and 12 months
insulin resistance index
Measured: Measured at 0, 3, 6, and 12 months
islet β-cell function index
Measured: Measured at 0, 3, 6, and 12 months
lipid Lipid accumulation product
Measured: Measured at 0, 3, 6, and 12 months
visceral adiposity index
Measured: Measured at 0, 3, 6, and 12 months
Measurement Results of Tumor Necrosis Factor-alpha Levels at Different Time Points
Measured: Measured at 0, 3, 6, and 12 months
Concentration Variation of Interleukin-10
Measured: Measured at 0, 3, 6, and 12 months
Change in Homocysteine Levels
Measured: Measured at 0, 3, 6, and 12 months
Average Concentration of Interleukin-6
Measured: Measured at 0, 3, 6, and 12 months
Change in Endothelin-1 Levels
Measured: Measured at 0, 3, 6, and 12 months
Average Concentration of Nitric Oxide
Measured: Measured at 0, 3, 6, and 12 months
Concentration Variation of Von Willebrand Factor
Measured: Measured at 0, 3, 6, and 12 months
Measurement Results of Vascular Endothelial Growth Factor Levels at Different Time Points
Measured: Measured at 0, 3, 6, and 12 months
Change in Matrix Metalloproteinase-9 Levels" or "Participants' Matrix Metalloproteinase-9 Concentration
Measured: Measured at 0, 3, 6, and 12 months
Average Concentration of Soluble Intercellular Adhesion Molecule-1
Measured: Measured at 0, 3, 6, and 12 months
Change in Serum Tau Protein Levels
Measured: Measured at 0, 3, 6, and 12 months
Average Concentration of Aβ40
Measured: Measured at 0, 3, 6, and 12 months
Average Concentration of Aβ42
Measured: Measured at 0, 3, 6, and 12 months
Change in Neurofilament Light Chain Protein Levels
Measured: Measured at 0, 3, 6, and 12 months
Carotid Ultrasound; Carotid Intima-Media Thickness.
Measured: 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: Measured at 0, 3, 6, and 12 months
Montreal Cognitive Assessment Score
The maximum score is 30 points, and the higher the score, the better the cognitive function.
Measured: Measured at 0, 3, 6, and 12 months
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: Measured at 0, 3, 6, and 12 months
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: Measured at 0, 3, 6, and 12 months
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: Measured at 0, 3, 6, and 12 months
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: Measured at 0 and 6 months respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start6 Jul 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qing Ni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qing Ni, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Qing Ni, postgraduate, Principal investigator, China Academy of Chinese Medical Sciences Guang'anmen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358118
- Sponsor's protocol ID
- 2024-003-KY
- Status last verified
- Jun 2024
- First submitted
- 2 Apr 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27500661Quinones 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.
PubMed 30815788Ji 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.
PubMed 23810406Carnethon 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.
PubMed 20569763Al 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.
PubMed 26257035Sinclair 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: 10.1016/j.diabres.2020.108078. Epub 2020 Feb 14.
PubMed 32068097Al-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.
PubMed 21059202Khan 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.
PubMed 32175717Ramtahal 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):S35-43. doi: 10.1016/j.jegh.2015.05.003. Epub 2015 Jun 11.
PubMed 26073574
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06358118
- Acronym / sponsor ID
- 2024-003-KY
- Conditions
- Diabete Mellitus, Aging, Metabolic Disorders, Traditional Chinese Medicine, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Qing NiUniversity, hospital or other
- Study start
- 6 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Buyuan Zhixiao FormulaTake Buyuan Zhixiao Formula granules |
| control group | Placebo comparator | Drug: PlaceboTake a placebos |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buyuan Zhixiao FormulaBuyuan Zhixiao Formula | Drug | experimental group |
| PlaceboThe placebo contains 10% of the active ingredients of the Chinese medicine group | Drug | control group |
Primary outcome
HbA1c
Time frame: Measured at 0, 3, 6, and 12 months respectively.
unit：%
38 secondary outcomes
Fasting blood glucose
Time frame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
2-hour postprandial blood glucose
Time frame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
blood pressure
Time frame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
weight
Time frame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
waist circumference
Time frame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
BMI
Time frame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively
Total Cholesterol
Time frame: Measured at 0, 3, 6, and 12 months
Triglycerides
Time frame: Measured at 0, 3, 6, and 12 months
High density lipoprotein cholesterol
Time frame: Measured at 0, 3, 6, and 12 months
Low density lipoprotein cholesterol
Time frame: Measured at 0, 3, 6, and 12 months
Ankle-Brachial Index（ABI）
Time frame: Measured at 0, 3, 6, and 12 months
Fasting insulin
Time frame: Measured at 0, 3, 6, and 12 months
C-peptide
Time frame: Measured at 0, 3, 6, and 12 months
insulin resistance index
Time frame: Measured at 0, 3, 6, and 12 months
islet β-cell function index
Time frame: Measured at 0, 3, 6, and 12 months
lipid Lipid accumulation product
Time frame: Measured at 0, 3, 6, and 12 months
visceral adiposity index
Time frame: Measured at 0, 3, 6, and 12 months
Measurement Results of Tumor Necrosis Factor-alpha Levels at Different Time Points
Time frame: Measured at 0, 3, 6, and 12 months
Concentration Variation of Interleukin-10
Time frame: Measured at 0, 3, 6, and 12 months
Change in Homocysteine Levels
Time frame: Measured at 0, 3, 6, and 12 months
Average Concentration of Interleukin-6
Time frame: Measured at 0, 3, 6, and 12 months
Change in Endothelin-1 Levels
Time frame: Measured at 0, 3, 6, and 12 months
Average Concentration of Nitric Oxide
Time frame: Measured at 0, 3, 6, and 12 months
Concentration Variation of Von Willebrand Factor
Time frame: Measured at 0, 3, 6, and 12 months
Measurement Results of Vascular Endothelial Growth Factor Levels at Different Time Points
Time frame: Measured at 0, 3, 6, and 12 months
Change in Matrix Metalloproteinase-9 Levels" or "Participants' Matrix Metalloproteinase-9 Concentration
Time frame: Measured at 0, 3, 6, and 12 months
Average Concentration of Soluble Intercellular Adhesion Molecule-1
Time frame: Measured at 0, 3, 6, and 12 months
Change in Serum Tau Protein Levels
Time frame: Measured at 0, 3, 6, and 12 months
Average Concentration of Aβ40
Time frame: Measured at 0, 3, 6, and 12 months
Average Concentration of Aβ42
Time frame: Measured at 0, 3, 6, and 12 months
Change in Neurofilament Light Chain Protein Levels
Time frame: Measured at 0, 3, 6, and 12 months
Carotid Ultrasound; Carotid Intima-Media Thickness.
Time frame: 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.
Time frame: Measured at 0, 3, 6, and 12 months
Montreal Cognitive Assessment Score
Time frame: Measured at 0, 3, 6, and 12 months
Fried Frailty Phenotype Scale
Time frame: Measured at 0, 3, 6, and 12 months
Activities of Daily Living Scale score
Time frame: Measured at 0, 3, 6, and 12 months
Mini Nutritional Rating Scale
Time frame: Measured at 0, 3, 6, and 12 months
Serum and urine metabolomics
Time frame: Measured at 0 and 6 months respectively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 27500661Nunes 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.
- Background: PubMed 30815788Quinones 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.
- Background: PubMed 23810406Ji 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.
- Background: PubMed 20569763Carnethon 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.
- Background: PubMed 26257035Al 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.
- Results publication: PubMed 32068097Sinclair 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: 10.1016/j.diabres.2020.108078. Epub 2020 Feb 14.
- Results publication: PubMed 21059202Al-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.
- Results publication: PubMed 32175717Khan 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.
- Results publication: PubMed 26073574Ramtahal 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):S35-43. doi: 10.1016/j.jegh.2015.05.003. Epub 2015 Jun 11.
- Individual participant dataSharing planned: No
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NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
RecruitingObservational study
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruiting
Enhancing Telemedicine for T2D
Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Ni, postgraduate principal investigator
China Academy of Chinese Medical Sciences Guang'anmen Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buyuan Zhixiao Formula in people with Diabete Mellitus and Aging, run by Qing Ni at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing Ni, postgraduate (13701253942, 1831479145@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Measured at 0, 3, 6, and 12 months respectively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06358118, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.