Diabetes Mellitus, Type 2 Clinical Trial
Official title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Affiliated Hospital of Nantong University | Nantong | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Affiliated Hospital of Nantong University |
China,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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