Effect of HMP on Diabetic Microangiopaemia in T2DM

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of Heart-Protecting Musk Pill on Diabetic Microangiopaemia in Type 2 Diabetes Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05095922
• Other study ID #: HMP2008007p
• Status: Recruiting
• Phase: Phase 4
• Start date: March 28, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: December 2023
• Source: Affiliated Hospital of Nantong University
• Contact: Xinlei Wang, doctor
• Phone: 086+13814707820
• Email: rubi221[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study mainly investigates the therapeutic effect of Heart-Protecting Musk Pill (HMP) on patients with diabetic microangiopathy. According to the indicators of diabetic nephropathy (DN), diabetic retinopathy (DR), oxidative stress and inflammatory factor in patients with diabetic microvascular disease after using HMP, the investigators aim to evaluate the effect of HMP on diabetic microangiopathy, oxidative stress and inflammation.

Description:

Diabetes can lead to many diseases as diabetic macrovascular and microvascular complications which result in high disability and mortality rate, thereby seriously affecting the quality of life and life expectancy of diabetic patients. It not only aggravates the family burden of patients, but also becomes the main burden of public health services around the world.

Diabetic nephropathy (DN) and diabetic retinopathy (DR) are more serious in diabetic microangiopathy. The glomerulus and retina have the similar tissue structure and physiological function. Therefore, when they are exposured to the same risk factors can lead to microcirculation damage of kidney and retina. DN and DR have similar pathogenesis and development processes. Although the susceptibility genes and cytokines of DN and DR are different, the two can still be predictors of each other and they often coexist in diabetic patients.

At present, there are few drugs with definite curative effect on the treatment of diabetic microangiopathy, therefore the treatment of diabetic microangiopathy is an aspect that urgently needs a breakthrough in chronic complications of diabetes. Traditional Chinese medicine has a history of preventing and treating diabetes for thousands of years. For the treatment of chronic complications of diabetes by Chinese medicine, although there are not many Chinese medicines that have obtained curative effects, it has indeed accumulated rich experience in the process of research and clinical treatment that Western medicine could not obtain. Therefore, seeking Chinese medicine to effectively treat diabetic microvascular disease has become a direction worthy of attention and research.

Heart-Protecting Musk Pill (HMP) is a commonly used drug in clinical treatment, which comprises seven medicinal substances: Radix Ginseng, Venenum Bufonis, Styrax, Calculus Bovis Artifactus, Cortex Cinnamomi, Borneolum Syntheticum and Artificial Moschus. HMP is a traditional Chinese medicinal compound, which has been effectively used for treating coronary heart disease (CHD) and diabetic macrovascular disease. However, studies on Chinese medicines that are partially similar to HMP have shown that they can improve diabetic retinopathy. Therefore, the study of the efficacy of HMP on diabetic microangiopathy is extremely valuable. Previous researches have shown that HMP owns the effects of reducing oxidative stress, improving inflammation, anti-plateleting aggregation, promoting plasmin activity, and improving hemodynamics. It is possible that HMP can delay or improve the occurrence and development of diabetic microangiopathy through the above effects and even other unclear mechanisms.

At present, the drugs used for clinical treatment of type 2 diabetic microangiopathy are limited. Although the pharmacological indications of HMP can be used to deal with the pathogenesis of diabetic microvascular complications, there is still no clinical study of HMP for the treatment of diabetic microvascular complications. Therefore, this study compared the differences in indicators related to diabetic nephropathy, diabetic retinopathy, oxidative stress, and inflammatory factors between the control group and the HMP group before and after treatment to clarify the therapeutic effect of HMP on diabetic microangiopaemia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Diabetes mellitus

• Prescribed for Valsartan Capsules and Calcium Dobesilate Capsules

Exclusion Criteria:

• Type 1 diabetes mellitus

• Secondary diabetes

• Malignant tumors

• Active infection

• Acute diabetic complications

• Macrovascular complications

• Mental illness

• Intellectual disability

• Impaired heart function

• Impaired liver function

• Impaired kidney function

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetic Angiopathies

Intervention

Drug:
• Heart-Protecting Musk Pill
Heart-Protecting Musk Pill (pill, 45mg, three times a day, 3 months)
• Valsartan Capsules
Valsartan Capsules(capsule, 80mg, once a day, 3 months)
• Calcium Dobesilate Capsules
Calcium Dobesilate Capsules(capsule, 500mg, three times a day, 3 months)

Locations

Country	Name	City	State
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

References & Publications (5)

Deng X, Sun L, Lai X, Xiang L, Li Q, Zhang W, Zhang L, Sun S. Tea Polypeptide Ameliorates Diabetic Nephropathy through RAGE and NF-kappaB Signaling Pathway in Type 2 Diabetes Mice. J Agric Food Chem. 2018 Nov 14;66(45):11957-11967. doi: 10.1021/acs.jafc.8b04819. Epub 2018 Nov 1. — View Citation

Fan X, Shi M, Wang Y, Liang Q, Luo G. Transcriptional profiling analysis of HMP-treated rats with experimentally induced myocardial infarction. J Ethnopharmacol. 2011 Sep 1;137(1):199-204. doi: 10.1016/j.jep.2011.05.010. Epub 2011 May 13. — View Citation

Geraldes P, King GL. Activation of protein kinase C isoforms and its impact on diabetic complications. Circ Res. 2010 Apr 30;106(8):1319-31. doi: 10.1161/CIRCRESAHA.110.217117. — View Citation

Lu L, Qin Y, Chen C, Zhang X, Xu X, Lv C, Wan X, Ruan W, Guo X. The atheroprotective roles of heart-protecting musk pills against atherosclerosis development in apolipoprotein E-deficient mice. Ann Transl Med. 2019 Dec;7(23):714. doi: 10.21037/atm.2019.12.22. — View Citation

Zhang X, Saaddine JB, Chou CF, Cotch MF, Cheng YJ, Geiss LS, Gregg EW, Albright AL, Klein BE, Klein R. Prevalence of diabetic retinopathy in the United States, 2005-2008. JAMA. 2010 Aug 11;304(6):649-56. doi: 10.1001/jama.2010.1111. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of biochemical Indicators	Total cholesterol(TC), Triglycerides(TG), High-density lipoprotein cholesterol(HDL-C), Low-density lipoprotein cholesterol(LDL-C), Fasting blood glucose(FBG), Blood urea nitrogen(BUN)	Change from Baseline TC, TG, HDL-C, LDL-C, FBG, BUN at 3 months
Primary	Concentration of Glycosylated hemoglobin	Glycosylated hemoglobin(HbA1c)	Change from Baseline HbA1c at 3 months
Primary	Concentration of hypersensitive-c-reactive-protein and Cystatin C	hypersensitive-c-reactive-protein(hs-CRP), Cystatin C(CysC)	Change from Baseline hs-CRP and CysC at 3 months
Primary	Concentration of Serum creatinine	Serum creatinine(Scr)	Change from Baseline Scr at 3 months
Primary	Rate of estimated Glomerular Filtration	estimated Glomerular Filtration Rate(eGFR)	Change from Baseline eGFR at 3 months
Primary	Ratio of Urinary albumin to creatinine	Urinary albumin to creatinine Ratio(UACR)	Change from Baseline UACR at 3 months
Primary	Concentration of Serum fatty acid binding protein 4	Serum fatty acid binding protein 4(FABP4)	Change from Baseline FABP4 at 3 months
Primary	Indicators of diabetic retinopathy	The vision and fundus photography will be checked by an ophthalmologist to determine the effect.	Change from Baseline effect at 3 months
Primary	Concentration of inflammation indicator	Tumor Necrosis Factor-a(TNF-a)	Change from Baseline TNF-a at 3 months
Primary	Concentration of inflammation indicator	Vascular Endothelial Growth Factor(VEGF)	Change from Baseline VEGF at 3 months
Primary	Concentration of inflammation indicator	CC chemokine ligand 3(CCL3)	Change from Baseline CCL3 at 3 months
Primary	Concentration of Oxidative stress indicator	Superoxide dismutase(SOD)	Change from Baseline SOD at 3 months
Primary	Concentration of Oxidative stress indicator	Glutathione peroxidase(GSH-Px)	Change from Baseline GSH-Px at 3 months
Primary	Concentration of Oxidative stress indicator	Reactive oxygen species(ROS)	Change from Baseline ROS at 3 months
Primary	Clinical characteristics	Height, Waistline	Change from Baseline Height, Waistline at 3 months
Primary	Clinical characteristic	Weight	Change from Baseline Weight at 3 months
Primary	Blood pressure	Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP)	Change from Baseline SBP, DBP at 3 months