Effect of HMP on Diabetic Microangiopaemia in T2DM

July 8, 2024 updated by: Affiliated Hospital of Nantong University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nantong, Jiangsu, China, 226000
        • Affiliated Hospital of Nantong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heart-Protecting Musk Pill group
Heart-Protecting Musk Pill (pill, 45mg, three times a day, 3 months)+Valsartan Capsules(capsule, 80mg, once a day, 3 months）+Calcium Dobesilate Capsules (capsule, 500mg, three times a day, 3 months)
Drug: Heart-Protecting Musk Pill
Heart-Protecting Musk Pill (pill, 45mg, three times a day, 3 months)
Other Names:
  • Heart-Protecting Musk Pill，National Medicine Permission Number Z31020068，86900674000453
Drug: Valsartan Capsules
Valsartan Capsules(capsule, 80mg, once a day, 3 months）
Other Names:
  • Valsartan Capsules，National Medicine Permission Number H20040217，86900100000095
Drug: Calcium Dobesilate Capsules
Calcium Dobesilate Capsules(capsule, 500mg, three times a day, 3 months)
Other Names:
  • Doxium，H20140641
Placebo Comparator: Control group
Valsartan Capsules(capsule, 80mg, once a day, 3 months), Calcium Dobesilate Capsules (capsule, 500mg, three times a day, 3 months)
Drug: Valsartan Capsules
Valsartan Capsules(capsule, 80mg, once a day, 3 months）
Other Names:
  • Valsartan Capsules，National Medicine Permission Number H20040217，86900100000095
Drug: Calcium Dobesilate Capsules
Calcium Dobesilate Capsules(capsule, 500mg, three times a day, 3 months)
Other Names:
  • Doxium，H20140641

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Nantong University

Investigators

  • Study Director: Xinlei Wang, Affiliated Hospital of Nantong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2023

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

July 9, 2024

Last Update Submitted That Met QC Criteria

July 8, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMP2008007p

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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