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

NCT06358118 | Not Yet Recruiting

• 1 other identifier: 2024-003-KY
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 6

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. 1.What are the clinical effects of Buyuan Zhixiao Formula, including lowering blood sugar, lowering blood pressure, lowering lipids, and treating obesity?
2. 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.
3. 3.Take the drug Bu Yuan Zhi XiaoFormula or placebo every day for 6 months；Follow-up for 6 months；
4. 4.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;
5. 5.Conduct scores on TCM symptoms, cognitive ability, nutritional status and other scales and adverse events;
6. 6.Urine and serum samples were collected before and after treatment;

Conditions

Diabete Mellitus; Aging; Metabolic Disorders; Traditional Chinese Medicine; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• HbA1c

  unit：%

  Measured at 0, 3, 6, and 12 months respectively.

Secondary Outcomes (38)

• Fasting blood glucose

  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

• blood pressure

  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

Study Arms (2)

experimental group

EXPERIMENTAL

Take Buyuan Zhixiao Formula granules

Drug: Buyuan Zhixiao Formula

control group

PLACEBO COMPARATOR

Take a placebos

Drug: Placebo

Interventions

Buyuan Zhixiao Formula DRUG

Buyuan Zhixiao Formula

experimental group

Placebo DRUG

The placebo contains 10% of the active ingredients of the Chinese medicine group

control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥65 years, irrespective of sex;
• 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;
• Compliance with the diagnostic criteria for abdominal obesity (waist circumference ≥90 cm for males and ≥85 cm for females);
• Conformity to the diagnostic standards for hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg);
• 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;
• 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》;
• Willingness to sign an informed consent document.

You may not qualify if:

• Individuals who have participated in other pharmacological clinical trials within the past month.
• 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.

Sponsors & Collaborators

• Qing Ni: lead

Study Sites (6)

China Academy of Chinese Medical Sciences Guang'anmen Hospital

Beijin, Beijing Municipality, 100053, China

Location

Cangzhou integrative medicine hospital

Hebei, China

Location

Hohhot Mongolian Traditional Chinese Medicine Hospital

Neimeng, China

Location

Binzhou Traditional Chinese Medicine Hospital

Shandong, China

Location

Yantai Baishi Traditional Chinese Medicine Hospital

Shandong, China

Location

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, China

Location

Related Publications (9)

• 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.

  PMID: 27500661 BACKGROUND

• 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.

  PMID: 30815788 BACKGROUND

• 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.

  PMID: 23810406 BACKGROUND

• 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.

  PMID: 20569763 BACKGROUND

• 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.

  PMID: 26257035 BACKGROUND

• 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: 10.1016/j.diabres.2020.108078. Epub 2020 Feb 14.

  PMID: 32068097 RESULT

• 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.

  PMID: 21059202 RESULT

• 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.

  PMID: 32175717 RESULT

• 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):S35-43. doi: 10.1016/j.jegh.2015.05.003. Epub 2015 Jun 11.

  PMID: 26073574 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Metabolic Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Qing Ni, postgraduate

  China Academy of Chinese Medical Sciences Guang'anmen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing Ni, postgraduate

CONTACT

13701253942; 1831479145@qq.com

zhige Wen, postgraduate

CONTACT

15890643963; 1831479145@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 10, 2024
• Study Start: July 6, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)