Effect of HMP on Diabetic Microangiopaemia in T2DM

NCT05095922 | Completed Phase 4

• 1 other identifier: HMP2008007p
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Diabetic Angiopathies

Keywords

Heart-protecting musk pill; type 2 diabetes; diabetic angiopathies

Outcome Measures

Primary Outcomes (17)

• 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

• Concentration of Glycosylated hemoglobin

  Glycosylated hemoglobin(HbA1c)

  Change from Baseline HbA1c at 3 months

• 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

• Concentration of Serum creatinine

  Serum creatinine(Scr)

  Change from Baseline Scr at 3 months

• Rate of estimated Glomerular Filtration

  estimated Glomerular Filtration Rate(eGFR)

  Change from Baseline eGFR at 3 months

• Ratio of Urinary albumin to creatinine

  Urinary albumin to creatinine Ratio(UACR)

  Change from Baseline UACR at 3 months

• Concentration of Serum fatty acid binding protein 4

  Serum fatty acid binding protein 4（FABP4)

  Change from Baseline FABP4 at 3 months

• 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

• Concentration of inflammation indicator

  Tumor Necrosis Factor-α(TNF-α)

  Change from Baseline TNF-α at 3 months

• Concentration of inflammation indicator

  Vascular Endothelial Growth Factor(VEGF)

  Change from Baseline VEGF at 3 months

• Concentration of inflammation indicator

  CC chemokine ligand 3(CCL3)

  Change from Baseline CCL3 at 3 months

• Concentration of Oxidative stress indicator

  Superoxide dismutase(SOD)

  Change from Baseline SOD at 3 months

• Concentration of Oxidative stress indicator

  Glutathione peroxidase(GSH-Px)

  Change from Baseline GSH-Px at 3 months

• Concentration of Oxidative stress indicator

  Reactive oxygen species(ROS）

  Change from Baseline ROS at 3 months

• Clinical characteristics

  Height, Waistline

  Change from Baseline Height, Waistline at 3 months

• Clinical characteristic

  Weight

  Change from Baseline Weight at 3 months

• Blood pressure

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

  Change from Baseline SBP, DBP at 3 months

Study Arms (2)

Heart-Protecting Musk Pill group

EXPERIMENTAL

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; Drug: Valsartan Capsules; Drug: Calcium Dobesilate Capsules

Control group

PLACEBO COMPARATOR

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

Drug: Valsartan Capsules; Drug: Calcium Dobesilate Capsules

Interventions

Heart-Protecting Musk Pill DRUG

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

Also known as: Heart-Protecting Musk Pill，National Medicine Permission Number Z31020068，86900674000453

Heart-Protecting Musk Pill group

Valsartan Capsules DRUG

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

Also known as: Valsartan Capsules，National Medicine Permission Number H20040217，86900100000095

Control group; Heart-Protecting Musk Pill group

Calcium Dobesilate Capsules DRUG

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

Also known as: Doxium，H20140641

Control group; Heart-Protecting Musk Pill group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Diabetes mellitus
• Prescribed for Valsartan Capsules and Calcium Dobesilate Capsules

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

Location

Related Publications (5)

• 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.

  PMID: 20699456 BACKGROUND

• 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.

  PMID: 20431074 BACKGROUND

• 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.

  PMID: 30354109 BACKGROUND

• 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.

  PMID: 32042730 BACKGROUND

• 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.

  PMID: 21605651 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Angiopathies

Interventions

Valsartan; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Xinlei Wang

  Affiliated Hospital of Nantong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The type 2 diabetes subjects with diabetic microangiopathy

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 27, 2021
• Study Start: March 28, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: July 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)