Effect and Safety of Herbal Medicine Foot Baths in Patients with Diabetic Peripheral Neuropathy: A Multicenter Double-Blind Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect and safety of foot baths with Tangbi Waixi Decoction (TW) in treating patients with diabetic peripheral neuropathy (DPN). METHODS: It is a multicenter double-blinded randomized controlled trial. Participants with DPN were recruited between November 18, 2016 and May 30, 2018 from 8 hospitals in China. All patients received basic treatments for glycemic management. Patients received foot baths with TW herbal granules either 66.9 g (intervention group) or 6.69 g (control group) for 30 min once a day for 2 weeks and followed by a 2-week rest, as a therapeutic course. If the Toronto Clinical Scoring System total score (TCSS-TS) ⩾6 points, the patients received a total of 3 therapeutic courses (for 12 weeks) and were followed up for 12 weeks. The primary outcome was change in TCSS-TS score at 12 and 24 weeks. Secondary outcomes included changes in bilateral motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of the median and common peroneal nerve. Safety was also assessed. RESULTS: Totally 632 patients were enrolled, and 317 and 315 were randomized to the intervention and control groups, respectively. After the 12-week intervention, patients in both groups showed significant declines in TCSSTS scores, and significant increases in MNCV and SNCV of the median and common peroneal nerves compared with pre-treatment (P<0.05). The reduction of TCSS-TS score at 12 weeks and the increase of SNCV of median nerve at 24 weeks in the control group were greater than those in the intervention group (P<0.05). The number of adverse events did not differ significantly between groups (P>0.05), and no serious adverse event was related with treatment. CONCLUSION: Treatment of TW foot baths was safe and significantly benefitted patients with DPN. A low dose of TW appeared to be more effective than a high dose. (Registry No. ChiCTR-IOR-16009331).

The changes in miR-130b levels in human serum and the correlation with the severity of diabetic nephropathy.

BACKGROUND: Circulating microRNA 130b has been closely associated with multiple diseases in humans such as cancer, obesity and diabetes mellitus. This study evaluates the correlation between serum miR-130b and the severity of diabetic nephropathy evaluated by measurement of albuminuria. METHODS: Three hundred twenty-seven patients with type 2 diabetes mellitus (T2DM) were divided into three groups: normoalbuminuria group [diabetes mellitus, urinary albumin to creatinine ratio (UACR) < 30 mg/g, n = 137], microalbuminuria group (DN1, UACR 30-300 mg/g, n = 122) and macroalbuminuria group (DN2, UACR > 300 mg/g, n = 68). The levels of serum miR-130b were validated by real-time polymerase chain reaction. Serum transforming growth factor ß1 (TGF-ß1), hypoxia inducible factor 1α (HIF-1α) and fibronectin were determined by enzyme-linked immunosorbent assay. RESULTS: Compared with control, serum miR-130b levels were significantly decreased in T2DM patients and further decreased in the patients of diabetes mellitus, DN1 and DN2 groups (p < 0.001). Furthermore, age-adjusted and sex-adjusted regression analyses showed that decreased level of serum miR-130b, increased levels of glycated haemoglobin (HbA1c ), homeostatic model assessment of insulin resistance (HOMA-IR), triglyceride (TG), low-density lipoprotein (LDL), serum creatinine, blood urea nitrogen (BUN), TGF-ß1, HIF-1α and fibronectin were significantly correlated with UACR (p < 0.05). In addition, serum miR-130b levels were inversely correlated with HbA1c , HOMA-IR, TG, LDL, BUN, TGF-ß1, HIF-1α and FN (p < 0.05). CONCLUSION: Our findings suggest that serum miR-130b may be a new biomarker for the early diagnosis of DN in T2DM. Circulating miR-130b may possibly be involved in the pathological mechanism of DN, such as lipid metabolic disorders, oxidative stress, extracellular matrix deposition and renal fibrosis.

Alpha Lipoic Acid Modulated High Glucose-Induced Rat Mesangial Cell Dysfunction via mTOR/p70S6K/4E-BP1 Pathway.

The aim of this study was to investigate whether alpha lipoic acid (LA) regulates high glucose-induced mesangial cell proliferation and extracellular matrix production via mTOR/p70S6K/4E-BP1 signaling. The effect of LA on high glucose-induced cell proliferation, fibronectin (FN), and collagen type I (collagen-I) expression and its mechanisms were examined in cultured rat mesangial cells by methylthiazol tetrazolium (MTT) assay, flow cytometry, ELISA assay, and western blot, respectively. LA at a relatively low concentration (0.25 mmol/L) acted as a growth factor in rat mesangial cells, promoted entry of cell cycle into S phase, extracellular matrix formation, and phosphorylated AKT, mTOR, p70S6K, and 4E-BP1. These effects disappeared when AKT expression was downregulated with PI3K/AKT inhibitor LY294002. Conversely, LA at a higher concentration (1.0 mmol/L) inhibited high glucose-induced rat mesangial cell proliferation, entry of cell cycle into S phase, and extracellular matrix exertion, as well as phosphorylation of mTOR, p70S6K, and 4E-BP1 but enhanced the activity of AMPK. However, these effects disappeared when AMPK activity was inhibited with CaMKK inhibitor STO-609. These results suggest that LA dose-dependently regulates mesangial cell proliferation and matrix protein secretion by mTOR/p70S6K/4E-BP1 signaling pathway under high glucose conditions.

[Brachial ankle pulse wave velocity in the patients of metabolic syndrome].

OBJECTIVE: To investigate the association between metabolic syndrome (MS) and brachial ankle pulse wave velocity (baPWV). METHODS: A total of 5476 subjects were enrolled from annual health checkups. Blood pressure, fasting plasma glucose, waist circumference, triglyceride, cholesterol, high-density and low-density lipoprotein cholesterols were measured routinely. And baPWV was determined by VP-1000 (BP-203RPE III). RESULTS: The values of baPWV and its change rates in MS patients were both higher than those in non-MS subjects respectively (1419.0 (1284.0 - 1586.5) cm/s vs 1275.0 (1160.5 - 1419.6) cm/s, 16.3% (6.6% - 27.3%) vs 7.1% (1.0% - 17.2%), both P < 0.01). Systolic blood pressure, fasting blood glucose, low-density lipoprotein cholesterol and triglyceride were the important influencing components of baPWV. CONCLUSION: MS patients have early alterations of arterial wall elasticity and function. And examination of pulse wave velocity helps to screen early arteriosclerosis.