[Association between remnant cholesterol levels and incident diabetic retinopathy in middle-aged and older patients with diabetes].

Objective: To investigate the association between remnant cholesterol (RC) and the risk of diabetic retinopathy (DR) in middle-aged and older individuals with diabetes. Methods: Based on the Shanghai Nicheng Cohort Study database, the data of 1 255 individuals with diabetes aged 55-70 years at baseline (2013-2014) with complete fundus photographs and serum cholesterol data in Nicheng, Shanghai, were analyzed. Multinomial logistic regression models were used to evaluate risk ratios (RRs) and their 95% confidence intervals (CIs) between baseline RC level and incident DR. Results: The median age of the subjects was 61.9 years, and 60.4% were women. After a 4.6-year follow-up, 79 (6.3%) patients developed DR, including 50 (4.0%) mild non-proliferative DR and 29 (2.3%) referable DR (RDR). Multivariable logistic regression showed that each mmol/L increase of RC was associated with a 40% higher risk of RDR (RR=1.40, 95%CI 1.03-1.90). Compared with the lowest tertile of RC (<0.63 mmol/L), the risk of RDR in the highest tertile (≥0.85 mmol/L) increased by 4.59 times (RR=5.59, 95%CI 1.51-20.73). Conclusion: The RC level may help identify individuals at high risk of incident RDR in middle-aged and older Chinese adults with diabetes.

[Efficacy and safety of ultra rapid lispro in the treatment of type 2 diabetes mellitus: a randomized controlled clinical trial].

Objective: To evaluate and compare the efficacy and safety of ultra-rapid lispro insulin (URLi) and humalog lispro (HL) in the treatment of type 2 diabetes mellitus. Methods: This was an international multicenter, double-blind, randomized controlled study. From May 2019 to January 2021, a total of 481 patients with type 2 diabetes mellitus, who had been using insulin for at least 90 days and had poor glycemic control, were included. These patients were recruited from 34 research centers in China, including Shanghai Jiao Tong University School of Medicine Affiliated Sixth People's Hospital. They were assigned to either the URLi group (319 patients) or the HL group (162 patients) using stratified blocked randomization. The primary endpoint was the change in hemoglobin A1c (HbA1c) relative to baseline after 26 weeks of treatment. Secondary endpoints included the proportion of patients who achieved HbA1c<7.0% and ≤6.5% after 26 weeks of treatment, 1-h postprandial glucose (1hPG) or 2-h postprandial glucose (2hPG) excursions during a mixed meal tolerance test at week 26, as well as safety parameters. Continuous variables were compared using mixed model repeated measures or analysis of covariance, and categorical variables were compared using logistic regression or Fisher's exact test. Results: Data based on the Chinese subgroup showed that there were no statistically significant differences between the URLi and HL groups in terms of male percentage [56.1% (179/319) vs. 56.2% (91/162); P=0.990], age [(59.5±8.4) vs. (59.6±9.3) years; P=0.839] and other baseline characteristics. Regarding the change in HbA1c relative to baseline, the URLi group was non-inferior to the HL group (-0.59%±0.05% vs. -0.66%±0.06%; P=0.312). There were no statistically significant differences between the URLi and HL groups in proportion of patients who achieved HbA1c<7.0% [47.3% (138/292) vs. 45.2% (70/155); P=0.907] and≤6.5% [27.7% (81/292) vs. 27.7% (43/155); P=0.816]. The excursions in 1hPG [(6.20±0.21) vs. (6.90±0.25) mmol/L; P=0.001] and 2hPG [(8.10±0.27) vs. (9.30±0.31) mmol/L; P<0.001] were lower in the URLi group than the HL group, with statistically significant differences. In terms of safety, there were no statistically significant differences in the percentage of subjects who reported treatment-emergent adverse events between the URLi and HL groups [49.8% (159/319) vs. 50.0% (81/162); P=1.000]. The event rate of nocturnal hypoglycemia was lower in the URLi group than the HL group, with statistically significant differences [(0.53±0.10) vs. (0.89±0.16) events per patient-year; P=0.040]. Conclusions: With good glycemic control, URLi showed non-inferiority for HbA1c improvement versus HL and was superior to HL for postprandial glucose excursion control. Meanwhile the rate and incidence of nocturnal hypoglycemia were lower in the URLi group than the HL group.

[Comparison of efficacy and safety of insulin aspart injection Rishulin and NovoRapid for treatment of diabetes: a multicenter, randomized, open-labeled, controlled trial].

Objective: To compare the efficacy and safety of Tonghua Dongbao's insulin aspart injection (Rishulin) and NovoRapid (Novo Nordisk) in the treatment of diabetes. Methods: A 26-week, randomized, open-label, parallel-group, positive control drug and non-inferiority trial was conducted in 23 centers in China. A total of 563 diabetes with poor blood glucose control treated with insulin for at least 3 months before were included. The subjects were randomized(stratified block random method) into those receiving Rishulin or NovoRapid at a ratio of 3∶1. Both groups were combined with basal insulin (Lantus). The primary endpoint was the change in glycosylated hemoglobin (HbA1c) from baseline to the end of 24 weeks of treatment. Results: For full analysis set, after 24 weeks of treatment, HbA1c level of Ruishulin group decreased from (8.66±1.28)% to (7.77±1.09)% (P<0.001), and that of NovoRapid group decreased from (8.47±1.28) % to (7.65±0.97) % (P<0.001). Treatment difference in HbA1c (NovoRapid group-Ruishulin group) was -0.061% (95%CI -0.320-0.199). HbA1c<7.0% target reacing rates were 24.26% and 21.21% (P=0.456), and HbA1c<6.5% target reacing rates were 9.65% and 6.82% (P=0.310) in Ruishulin group and NovoRapid group, repectively. The standard 2 hours postprandial blood glucose (2hPG) in Ruishulin group decreased from (16.23±5.22) mmol/L to (12.65±4.57) mmol/L (P<0.001), and 2hPG in NovoRapid group decreased from (16.13±5.37) mmol/L to (11.91)±4.21) mmol/L (P<0.001). The fingertips blood glucose at 7-point of both groups exhibited varying degrees of reduction compared with those at baseline, repectively. Positive ratios of specific antibodies were 31.68% in Ruishulin group and 36.36% in NovoRapid group (P=0.320). Ratios of negative to positive were 7.43% and 10.61% (P=0.360), and ratios of positive to negative were 10.40% and 7.58% (P=0.360) in Ruishulin group and NovoRapid group, respectively. The incidence of hypoglycemia was 60.05% and 55.40% (P=0.371), and the incidence of adverse events was 76.60% and 77.70% (P=0.818) in Ruishulin group and NovoRapid group, respectively. Conclusions: Rishulin is not inferior to NovoRapid, and has shown good efficacy and safety. It can be an ideal choice for clinicians in patients with poor blood glucose control with insulin.

[Research on consistency of different measurement methods for saliva 1,5-anhydroglucitol].

Objective: To evaluate the consistency of different measurement methods of saliva 1,5-anhydroglucitol (1,5-AG) in different glucose metabolism populations. Methods: From January 2018 to June 2019, 175 healthy volunteers (21-65 years, 58 males and 117 females) with normal glucose tolerance (NGT) and 80 diabetic patients (18-70 years, 44 males and 36 females) were enrolled in Shanghai Jiao Tong University Affiliated Sixth People's Hospital. Saliva was collected by saliva collection tube, and 1,5-AG was measured using both enzymatic and mass spectrometry methods. Serum 1,5-AG was determined by enzymatic method. Results: In NGT subjects, both serum and saliva 1,5-AG levels detected by enzymatic method were positively correlated with the saliva 1,5-AG levels detected by liquid chromatography-mass spectrometry (r=0.247 and 0.523, respectively, both P<0.05). However, there was no significant correlation between saliva and serum 1,5-AG levels detected by enzymatic method (r=-0.074, P=0.333). In diabetic patients, both serum and saliva 1,5-AG levels detected by enzymatic method were positively correlated with the saliva 1,5-AG levels detected by gas chromatography-mass spectrometry (r=0.284 and 0.423, respectively, both P<0.05). However, there was no significant correlation between saliva and serum 1,5-AG levels detected by enzymatic method (r=-0.079, P=0.487). Conclusions: Both serum and saliva 1,5-AG levels detected by enzymatic method have a good consistency with saliva 1,5-AG levels detected by mass spectrometry method. The saliva and serum 1,5-AG levels detected by enzymatic method are not well correlated, and thus the enzymatic detection of saliva 1,5-AG needs further improvement in clinical practice.

[The appropriate cut-off point of time in range (TIR) for evaluating glucose control in type 2 diabetes mellitus].

Objective: To investigate the appropriate cut-off point of time in range (TIR) for evaluating glucose control in type 2 diabetes mellitus (T2DM) patients, and analyze the prevalence of abnormal carotid intima-media thickness (CIMT) and diabetic retinopathy (DR) in different TIR categories. Methods: A total of 2 161 subjects with T2DM (1 183 males) were enrolled from hospitalized patients at the Department of Endocrinology and Metabolism of the Sixth People's Hospital Affiliated to Shanghai Jiao Tong University from January 2005 to February 2012. The age of the enrolled participants was (60.4±11.9) years. Each patient underwent continuous glucose monitoring (CGM) for three consecutive days, then TIR (3.9-10.0 mmol/L), time above range (TAR) and time below range (TBR) were calculated. Fundus photography and carotid artery Doppler ultrasound were performed to diagnose DR and abnormal CIMT (defined as CIMT≥1.0 mm), respectively. Multivariate logistic regression models were used to examine the independent association of different TIR groups with CIMT and DR. Results: All subjects were divided into 4 groups according to TIR:≤40%, 41%-70%, 71%-85% and>85%. Significant linear trends in age, diabetes duration, body mass index (BMI), total cholesterol, glycated hemoglobin A1c (HbA1c), TAR and mean glucose (MG) existed among the 4 groups (all P(trend)<0.05). However, there was only a weak correlation between TIR and TBR (<3.9 mmol/L) (r=0.087, P<0.001), and no significant association was observed between TBR (<3 mmol/L) and the TIR categories (P(trend)=0.378). The overall prevalence of abnormal CIMT and DR was 12.1% and 23.8%, respectively. The prevalence of abnormal CIMT in the 4 groups with ascending levels of TIR was 16.9% (59/349), 12.9% (96/746), 11.2% (57/510) and 9.0% (50/556) (P(trend)<0.001), respectively. And the prevalence of DR was 30.7% (107/349), 29.4% (219/746), 20.8% (106/510) and 14.9% (83/556), respectively (P(trend)<0.001). In the binary logistic regression model by adjusting confounding factors, compared with TIR≤ 40%, the risk of abnormal CIMT was reduced by 33.8% (OR=0.662, 95%CI: 0.456-0.963, P=0.031), 40.8% (OR=0.592, 95%CI: 0.390-0.899, P=0.014), and 45.0% (OR=0.550, 95%CI: 0.358-0.846, P=0.006) in the other three groups, respectively. And the risk of DR was reduced by 2.9% (OR=0.971, 95%CI: 0.725-1.301, P=0.844), 33.4%(OR=0.666, 95%CI: 0.479-0.924, P=0.015) and 53.3% (OR=0.467, 95%CI: 0.331-0.657, P<0.001), respectively. Conclusion: Using 40%, 70% and 85% as cut-off point of TIR helps stratify the risk of diabetic complications, and assess the glucose control (Poor: TIR≤40%; Unsatisfactory: TIR≤70%; Satisfactory: TIR>70%; Optimal: TIR>85%) in patients with T2DM.

Use of dynamic contrast-enhanced magnetic resonance imaging to evaluate the microcirculation of lower extremity muscles in patients with Type 2 diabetes.

AIMS: To quantify the capillary permeability of the lower extremity muscles using dynamic contrast-enhanced magnetic resonance imaging in healthy control subjects without diabetes and patients with diabetes before and after percutaneous angioplasty. METHODS: Fifty-five patients (30 without diabetes, 25 with Type 2 diabetes with occluded vasculature of the lower extremities) were examined by dynamic contrast-enhanced magnetic resonance imaging. The transfer constant (K-trans) of the tibialis anterior muscle was determined before (for all patients) and after (for patients with diabetes only) percutaneous angioplasty of the intrapopliteal artery. Clinical assessment was also recorded. Statistical significant differences were defined at the level of P < 0.05. RESULTS: Before percutaneous angioplasty, patients with diabetes displayed significantly lower K-trans values in the tibialis anterior muscles than control subjects. Although percutaneous angioplasty increased the K-trans of these patients, the final values were still less than those of the control group. Differences were also observed between the groups in the Fontaine classification and ankle-brachial index, which reflect ischaemia in the lower extremities. After percutaneous angioplasty, these values were increased in the group with diabetes. CONCLUSION: K-trans can be used to quantify changes in the capillary permeability of the lower extremity muscles, reflecting the microcirculation of the lower extremities.

Epidemiological characteristics of diabetes mellitus and impaired glucose regulation in a Chinese adult population: the Shanghai Diabetes Studies, a cross-sectional 3-year follow-up study in Shanghai urban communities.

AIMS/HYPOTHESIS: To estimate the prevalence and incidence of diabetes mellitus and impaired glucose regulation (IGR) in a Chinese population aged 20-94 years. SUBJECTS AND METHODS: A group of 5,628 randomly selected adults, aged 20-94 years, living in the Huayang and Caoyang communities in Shanghai, China, were investigated between 1998 and 2001. During 2002-04, 2,666 subjects were followed up. All the participants underwent anthropometric measurements, blood biochemical analyses and a 75-g OGTT. RESULTS: Based on the 2000 census data of China, the age-standardised prevalences were 6.87% for diabetes and 8.53% for IGR at baseline. More than two in five cases with diabetes were undiagnosed. The age-adjusted prevalence of diabetes and IGR increased with age. The age-adjusted prevalences of hypertension, dyslipidaemia and overweight in males were significantly higher (p < 0.001) than in females. The 3-year cumulative incidence rates of diabetes and IGR were 4.96 and 11.10%, respectively. The relative risk of developing diabetes was significantly higher in subjects with IGR than in subjects with NGT (p < 0.001). CONCLUSIONS/INTERPRETATION: The prevalence and incidence rates for diabetes or IGR have increased dramatically over the last decades, especially in younger age groups. A large proportion of cases are undiagnosed. We strongly recommend that population-based diabetes screening programmes should be implemented and generalised for younger people.

Pulmonary infarction presenting as aseptic cavitation.

A case of pulmonary infarction presenting as aseptic cavitation was reported. Basically, the patient suffered from rheumatic heart disease, mitral stenosis and insufficiency, and atrial fibrillation with predominant right heart enlargement. Hemoptysis, chest pain and dyspnea were present. Chest film simulated a thin wall lung abscess. The clinical picture suggested aseptic cavitation, which was confirmed by 99mTc-MAA lung scan.