search
Back to results

Effect of HMP on Diabetic Microangiopaemia in T2DM

Primary Purpose

Diabetes Mellitus, Type 2, Diabetic Angiopathies

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Heart-Protecting Musk Pill
Valsartan Capsules
Calcium Dobesilate Capsules
Sponsored by
Affiliated Hospital of Nantong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Heart-protecting musk pill, type 2 diabetes, diabetic angiopathies

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Affiliated Hospital of Nantong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Heart-Protecting Musk Pill group

Control group

Arm Description

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)

Valsartan Capsules(capsule, 80mg, once a day, 3 months), Calcium Dobesilate Capsules (capsule, 500mg, three times a day, 3 months)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 28, 2021
Last Updated
May 31, 2023
Sponsor
Affiliated Hospital of Nantong University
search

1. Study Identification

Unique Protocol Identification Number
NCT05095922
Brief Title
Effect of HMP on Diabetic Microangiopaemia in T2DM
Official Title
Effect of Heart-Protecting Musk Pill on Diabetic Microangiopaemia in Type 2 Diabetes Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
November 22, 2023 (Anticipated)
Study Completion Date
November 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital of Nantong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Diabetic Angiopathies
Keywords
Heart-protecting musk pill, type 2 diabetes, diabetic angiopathies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The type 2 diabetes subjects with diabetic microangiopathy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heart-Protecting Musk Pill group
Arm Type
Experimental
Arm Description
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)
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Valsartan Capsules(capsule, 80mg, once a day, 3 months), Calcium Dobesilate Capsules (capsule, 500mg, three times a day, 3 months)
Intervention Type
Drug
Intervention Name(s)
Heart-Protecting Musk Pill
Other Intervention Name(s)
Heart-Protecting Musk Pill,National Medicine Permission Number Z31020068,86900674000453
Intervention Description
Heart-Protecting Musk Pill (pill, 45mg, three times a day, 3 months)
Intervention Type
Drug
Intervention Name(s)
Valsartan Capsules
Other Intervention Name(s)
Valsartan Capsules,National Medicine Permission Number H20040217,86900100000095
Intervention Description
Valsartan Capsules(capsule, 80mg, once a day, 3 months)
Intervention Type
Drug
Intervention Name(s)
Calcium Dobesilate Capsules
Other Intervention Name(s)
Doxium,H20140641
Intervention Description
Calcium Dobesilate Capsules(capsule, 500mg, three times a day, 3 months)
Primary Outcome Measure Information:
Title
Concentration of biochemical Indicators
Description
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)
Time Frame
Change from Baseline TC, TG, HDL-C, LDL-C, FBG, BUN at 3 months
Title
Concentration of Glycosylated hemoglobin
Description
Glycosylated hemoglobin(HbA1c)
Time Frame
Change from Baseline HbA1c at 3 months
Title
Concentration of hypersensitive-c-reactive-protein and Cystatin C
Description
hypersensitive-c-reactive-protein(hs-CRP), Cystatin C(CysC)
Time Frame
Change from Baseline hs-CRP and CysC at 3 months
Title
Concentration of Serum creatinine
Description
Serum creatinine(Scr)
Time Frame
Change from Baseline Scr at 3 months
Title
Rate of estimated Glomerular Filtration
Description
estimated Glomerular Filtration Rate(eGFR)
Time Frame
Change from Baseline eGFR at 3 months
Title
Ratio of Urinary albumin to creatinine
Description
Urinary albumin to creatinine Ratio(UACR)
Time Frame
Change from Baseline UACR at 3 months
Title
Concentration of Serum fatty acid binding protein 4
Description
Serum fatty acid binding protein 4(FABP4)
Time Frame
Change from Baseline FABP4 at 3 months
Title
Indicators of diabetic retinopathy
Description
The vision and fundus photography will be checked by an ophthalmologist to determine the effect.
Time Frame
Change from Baseline effect at 3 months
Title
Concentration of inflammation indicator
Description
Tumor Necrosis Factor-α(TNF-α)
Time Frame
Change from Baseline TNF-α at 3 months
Title
Concentration of inflammation indicator
Description
Vascular Endothelial Growth Factor(VEGF)
Time Frame
Change from Baseline VEGF at 3 months
Title
Concentration of inflammation indicator
Description
CC chemokine ligand 3(CCL3)
Time Frame
Change from Baseline CCL3 at 3 months
Title
Concentration of Oxidative stress indicator
Description
Superoxide dismutase(SOD)
Time Frame
Change from Baseline SOD at 3 months
Title
Concentration of Oxidative stress indicator
Description
Glutathione peroxidase(GSH-Px)
Time Frame
Change from Baseline GSH-Px at 3 months
Title
Concentration of Oxidative stress indicator
Description
Reactive oxygen species(ROS)
Time Frame
Change from Baseline ROS at 3 months
Title
Clinical characteristics
Description
Height, Waistline
Time Frame
Change from Baseline Height, Waistline at 3 months
Title
Clinical characteristic
Description
Weight
Time Frame
Change from Baseline Weight at 3 months
Title
Blood pressure
Description
Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP)
Time Frame
Change from Baseline SBP, DBP at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinlei Wang, doctor
Phone
086+13814707820
Email
rubi221@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinlei Wang
Organizational Affiliation
Affiliated Hospital of Nantong University
Official's Role
Study Director
Facility Information:
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinlei Wang

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20699456
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.
Results Reference
background
PubMed Identifier
20431074
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.
Results Reference
background
PubMed Identifier
30354109
Citation
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.
Results Reference
background
PubMed Identifier
32042730
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.
Results Reference
background
PubMed Identifier
21605651
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.
Results Reference
background

Learn more about this trial

Effect of HMP on Diabetic Microangiopaemia in T2DM

We'll reach out to this number within 24 hrs