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NCT Number: NCT05095922

Effect of HMP on Diabetic Microangiopaemia in T2DM

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heart-Protecting Musk Pill

Drug

Heart-Protecting Musk Pill (pill, 45mg, three times a day, 3 months)

Other names: Heart-Protecting Musk Pill，National Medicine Permission Number Z31020068，86900674000453

Valsartan Capsules

Drug

Valsartan Capsules(capsule, 80mg, once a day, 3 months）

Other names: Valsartan Capsules，National Medicine Permission Number H20040217，86900100000095

Calcium Dobesilate Capsules

Drug

Calcium Dobesilate Capsules(capsule, 500mg, three times a day, 3 months)

Other names: Doxium，H20140641

Primary outcomes

  1. 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)

  2. Concentration of Glycosylated hemoglobin

    Time frame: Change from Baseline HbA1c at 3 months

    Glycosylated hemoglobin(HbA1c)

  3. 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)

  4. Concentration of Serum creatinine

    Time frame: Change from Baseline Scr at 3 months

    Serum creatinine(Scr)

  5. Rate of estimated Glomerular Filtration

    Time frame: Change from Baseline eGFR at 3 months

    estimated Glomerular Filtration Rate(eGFR)

  6. Ratio of Urinary albumin to creatinine

    Time frame: Change from Baseline UACR at 3 months

    Urinary albumin to creatinine Ratio(UACR)

  7. Concentration of Serum fatty acid binding protein 4

    Time frame: Change from Baseline FABP4 at 3 months

    Serum fatty acid binding protein 4（FABP4)

  8. 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.

  9. Concentration of inflammation indicator

    Time frame: Change from Baseline TNF-α at 3 months

    Tumor Necrosis Factor-α(TNF-α)

  10. Concentration of inflammation indicator

    Time frame: Change from Baseline VEGF at 3 months

    Vascular Endothelial Growth Factor(VEGF)

  11. Concentration of inflammation indicator

    Time frame: Change from Baseline CCL3 at 3 months

    CC chemokine ligand 3(CCL3)

  12. Concentration of Oxidative stress indicator

    Time frame: Change from Baseline SOD at 3 months

    Superoxide dismutase(SOD)

  13. Concentration of Oxidative stress indicator

    Time frame: Change from Baseline GSH-Px at 3 months

    Glutathione peroxidase(GSH-Px)

  14. Concentration of Oxidative stress indicator

    Time frame: Change from Baseline ROS at 3 months

    Reactive oxygen species(ROS）

  15. Clinical characteristics

    Time frame: Change from Baseline Height, Waistline at 3 months

    Height, Waistline

  16. Clinical characteristic

    Time frame: Change from Baseline Weight at 3 months

    Weight

  17. Blood pressure

    Time frame: Change from Baseline SBP, DBP at 3 months

    Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP)

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 27, 2021
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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