-
1.
The effect of periodic resistance training on obese patients with type 2 diabetic nephropathy.
Li, S, Yuan, S, Zhang, J, Xu, F, Zhu, F
Scientific reports. 2024;(1):2761
Abstract
Resistance training is an exercise against resistance designed to train the endurance and strength of muscle. To observe the effect of intervention of periodic resistance training on obese patients with type 2 diabetic nephropathy. A total of 60 obese patients with type 2 diabetic nephropathy were randomized into resistance training group and aerobic exercise group (30 patients each group) for observing the changes of blood glucose, body weight, blood lipid, insulin resistance, serum creatinine (Scr), urinary microalbumin, urinary albumin excretion rate (UAER) calculated by urinary creatinine, and glomerular filtration rate (GFR) after 12 weeks of intervention, and relevant significance as well. The number of patients with hypoglycemia during the intervention was also recorded. After 12 weeks of intervention, the weight, Body mass index (BMI), Waist, Triglyceride (TG), Cholesterol (TC), Low-density lipoprotein cholesterol (LDL), Fasting glucose (FBG), Fasting insulin (FINS), Glycosylated hemoglobin (HbA1c) and urine Albumin-Creatinine Ratio (uACR) were decreased and GFR was increased in both groups (P < 0.05), but the effect was more significant in the resistance training group. GFR was increased from 92.21 ± 10.67 mL/(min·1.73 m2) to 100.13 ± 12.99 mL/(min·1.73 m2) in resistance training group (P < 0.05). In the aerobic exercise group, GFR was increased from 89.98 ± 9.48 mL/(min·1.73 m2) to 92.51 ± 11.35 mL/(min·1.73 m2) (P > 0.05). Periodic resistance training can not only control the weight, blood sugar and blood lipid of obese patients with type 2 diabetic nephropathy, but also improve the urinary albumin excretion rate and glomerular filtration rate of early obese patients with type 2 diabetic nephropathy, and delay the progression of diabetic nephropathy. It is an effective non-drug intervention.
-
2.
Final efficacy analysis, interim safety analysis, and immunogenicity of a single dose of recombinant novel coronavirus vaccine (adenovirus type 5 vector) in adults 18 years and older: an international, multicentre, randomised, double-blinded, placebo-controlled phase 3 trial.
Halperin, SA, Ye, L, MacKinnon-Cameron, D, Smith, B, Cahn, PE, Ruiz-Palacios, GM, Ikram, A, Lanas, F, Lourdes Guerrero, M, Muñoz Navarro, SR, et al
Lancet (London, England). 2022;(10321):237-248
-
-
Free full text
-
Abstract
BACKGROUND The Ad5-nCoV vaccine is a single-dose adenovirus type 5 (Ad5) vectored vaccine expressing the SARS-CoV-2 spike protein that was well-tolerated and immunogenic in phase 1 and 2 studies. In this study, we report results on the final efficacy and interim safety analyses of the phase 3 trial. METHODS This double-blind, randomised, international, placebo-controlled, endpoint-case driven, phase 3, clinical trial enrolled adults aged 18 years older at study centres in Argentina, Chile, Mexico, Pakistan, and Russia. Participants were eligible for the study if they had no unstable or severe underlying medical or psychiatric conditions; had no history of a laboratory-confirmed SARS-CoV-2 infection; were not pregnant or breastfeeding; and had no previous receipt of an adenovirus-vectored, coronavirus, or SARS-CoV-2 vaccine. After informed consent was obtained, 25 mL of whole blood was withdrawn from all eligible participants who were randomised in a 1:1 ratio to receive a single intramuscular dose of 0·5 mL placebo or a 0·5 mL dose of 5 × 1010 viral particle (vp)/mL Ad5-nCoV vaccine; study staff and participants were blinded to treatment allocation. All participants were contacted weekly by email, telephone, or text message to self-report any symptoms of COVID-19 illness, and laboratory testing for SARS-CoV-2 was done for all participants with any symptoms. The primary efficacy objective evaluated Ad5-nCoV in preventing symptomatic, PCR-confirmed COVID-19 infection occurring at least 28 days after vaccination in all participants who were at least 28 days postvaccination on Jan 15, 2021. The primary safety objective evaluated the incidence of any serious adverse events or medically attended adverse events postvaccination in all participants who received a study injection. This trial is closed for enrolment and is registered with ClinicalTrials.gov (NCT04526990). FINDINGS Study enrolment began on Sept 22, 2020, in Pakistan, Nov 6, 2020, in Mexico, Dec 2, 2020, in Russia and Chile, and Dec 17, 2020, in Argentina; 150 endpoint cases were reached on Jan 15, 2021, triggering the final primary efficacy analysis. One dose of Ad5-nCoV showed a 57·5% (95% CI 39·7-70·0, p=0·0026) efficacy against symptomatic, PCR-confirmed, COVID-19 infection at 28 days or more postvaccination (21 250 participants; 45 days median duration of follow-up [IQR 36-58]). In the primary safety analysis undertaken at the time of the efficacy analysis (36 717 participants), there was no significant difference in the incidence of serious adverse events (14 [0·1%] of 18 363 Ad5-nCoV recipients and 10 [0·1%] of 18 354 placebo recipients, p=0·54) or medically attended adverse events (442 [2·4%] of 18 363 Ad5-nCoV recipients and 411 [2·2%] of 18 354 placebo recipients, p=0·30) between the Ad5-nCoV or placebo groups, or any serious adverse events considered related to the study product (none in both Ad5-nCoV and placebo recipients). In the extended safety cohort, 1004 (63·5%) of 1582 of Ad5-nCoV recipients and 729 (46·4%) of 1572 placebo recipients reported a solicited systemic adverse event (p<0·0001), of which headache was the most common (699 [44%] of Ad5-nCoV recipients and 481 [30·6%] of placebo recipients; p<0·0001). 971 (61·3%) of 1584 Ad5-nCoV recipients and 314 (20·0%) of 1573 placebo recipients reported an injection-site adverse event (p<0·0001), of which pain at the injection site was the most frequent; reported by 939 (59%) Ad5-nCoV recipients and 303 (19%) placebo recipients. INTERPRETATION One dose of Ad5-nCoV is efficacious and safe in healthy adults aged 18 years and older. FUNDING CanSino Biologics and the Beijing Institute of Biotechnology.
-
3.
Pharmacokinetics, safety and bioequivalence of two formulations of progesterone soft capsule in healthy Chinese postmenopausal females: Impacts of a high-fat meal.
Qin, H, Zheng, L, Fang, Y, Liu, Y, Liu, A, Wu, J, Zhu, F, Chen, J, Fan, Y, Hu, W
Basic & clinical pharmacology & toxicology. 2022;(2):268-276
-
-
Free full text
-
Abstract
Progesterone is an important natural hormone regulating ovulation and menstruation. The present study aimed to investigate the pharmacokinetics and safety of two formulations of progesterone in Chinese postmenopausal females under fasting and fed conditions. The study adopted a single-dose, open-label, randomized, three-period bioequivalence design. A total of 96 subjects were enrolled and randomly assigned to the fasting cohort or fed cohort. A high-fat meal (890 kcal) was used in the fed study. The reference-scaled average bioequivalence method was used for bioequivalence evaluation. A high-fat meal led to a 22-fold higher peak concentration (Cmax ) and a 7-fold higher area under the curve (AUC) while time to reach Cmax and half-life was not significantly affected. The concentration-time curve displayed double peaks suggesting the existence of enterohepatic circulation. The test/reference geometric mean ratios for Cmax and AUC under fasting and fed conditions are all within the range of 80% to 125%. All adverse events (AEs) that occurred during the trial were mild and did not cause drop-out, though these AEs occurred more frequently under fed state. In conclusion, the two formulations of progesterone are bioequivalent in Chinese subjects under fasting and fed conditions. Drug label modification regarding food effects needs further discussion.
-
4.
Roles of ursodeoxycholic acid in the bile biochemistry and metabolomics in patients with choledocholithiasis: a prospective study.
Guan, Y, Xu, F, Zhang, X, Fu, X, Wang, J, Song, S, Sun, Y, Yuan, Q, Zhu, F
Metabolomics : Official journal of the Metabolomic Society. 2022;(7):46
Abstract
INTRODUCTION Recurrence after the endoscopic treatment of common bile duct stones (CBDS) is related to bile metabolism and bile compositions. Ursodeoxycholic acid (UDCA) has been proved effective in reducing the recurrence of CBDS. However, the detailed effects of UDCA on bile metabolism are still not extensively explored. OBJECTIVES This study aimed to analyze the role of UDCA in patients with choledocholithiasis (CDC) from the perspective of biochemistry and metabolomics. METHODS A total of 89 patients with CDC who underwent endoscopic retrograde cholangiopancreatography were prospectively examined and randomly assigned to control and UDCA groups. The biochemical detections (cholesterol, bilirubin, and so on) were performed on the collected bile. Moreover, the metabolomics analysis was conducted based on bile from 20 patients in the UDCA group. RESULTS The bile levels of cholesterol and endotoxins significantly decreased after UDCA treatment. Regarding bile metabolomics, the levels of 25 metabolites changed significantly after UDCA treatment. The pathway enrichment analysis showed that the UDCA addition evoked a common response related to phenylalanine, tyrosine, and tryptophan biosynthesis; phenylalanine metabolism; arachidonic acid metabolism; and terpenoid backbone biosynthesis. CONCLUSIONS UDCA treatment within a short time interval (7 days) did not improve the circulating laboratory values in patients with CDC who had undergone endoscopy surgery. However, relevant decreases in the bile levels of cholesterol and endotoxin were observed. UDCA evoked a common response related to lipid metabolism and amino acid metabolism, which probably reduced the bile level of cholesterol, protected hepatocytes, and corrected the abnormality of lipid metabolism caused by CDC.
-
5.
The effect of periodic ketogenic diet on newly diagnosed overweight or obese patients with type 2 diabetes.
Li, S, Lin, G, Chen, J, Chen, Z, Xu, F, Zhu, F, Zhang, J, Yuan, S
BMC endocrine disorders. 2022;22(1):34
-
-
-
Free full text
Plain language summary
Currently, the ketogenic diet is gaining popularity in managing Type 2 diabetes (T2D). Ketogenic diets replace carbohydrates with fat and include limited carbohydrates and adequate protein. This randomised controlled trial evaluated the effects of the 12-week ketogenic diet on sixty overweight or obese T2D patients. Both the ketogenic and control diabetes diet groups achieved significant reductions in weight, body mass index, waist circumference, triglycerides, total cholesterol, low-density lipoprotein, high-density lipoprotein, fasting blood glucose, fasting insulin, and HbA1c. However, the ketogenic group showed significantly greater reductions in body mass, blood lipids, and blood glucose than the control group. In the ketogenic diet group, serum uric acid levels were higher than those in the control diet group. It was found that the control diet group adhered to the diet for a longer period than the ketogenic diet group, whose willingness to adhere to the diet long-term was weaker. More robust long-term studies are needed to evaluate the long-term effects of a ketogenic diet. In this study, more patients who followed the ketogenic diet experienced hypoglycaemic events during the first four weeks. Healthcare providers should exercise caution when recommending a short term therapeutic ketogenic diet.
Abstract
BACKGROUND The ketogenic diet (KD) is characterized by fat as a substitute of carbohydrates for the primary energy source. There is a large number of overweight or obese people with type 2 diabetes mellitus (T2DM), while this study aims to observe periodic ketogenic diet for effect on overweight or obese patients newly diagnosed as T2DM. METHODS A total of 60 overweight or obese patients newly diagnosed as T2DM were randomized into two groups: KD group, which was given ketogenic diet, and control group, which was given routine diet for diabetes, 30 cases in each group. Both dietary patterns lasted 12 weeks, and during the period, the blood glucose, blood lipid, body weight, insulin, and uric acid before and after intervention, as well as the significance for relevant changes, were observed. RESULTS For both groups, the weight, BMI(body mass index), Waist, TG (triglyceride), TC(cholesterol), LDL (low-density lipoprotein cholesterol), HDL (high-density lipoprotein cholesterol), FBG (fasting glucose), FINS (fasting insulin), HbA1c (glycosylated hemoglobin) were decreased after intervention (P < 0.05), while the decrease rates in the KD group was more significant than the control group. However, UA(serum uric acid) in the KD group showed an upward trend, while in the control group was not changed significantly (P > 0.05).The willingness to adhere to the ketogenic diet over the long term was weaker than to the routine diet for diabetes. CONCLUSION Among the overweight or obese patients newly diagnosed as type 2 diabetes mellitus, periodic ketogenic diet can not only control the body weight, but also control blood glucose and lipid, but long-term persistence is difficult.
-
6.
A 24-week, randomized, double-blind, active-controlled clinical trial comparing bexagliflozin with sitagliptin as an adjunct to metformin for the treatment of type 2 diabetes in adults.
Halvorsen, YD, Lock, JP, Zhou, W, Zhu, F, Freeman, MW
Diabetes, obesity & metabolism. 2019;(10):2248-2256
Abstract
AIM: To compare the relative safety and effectiveness of bexagliflozin and sitagliptin as adjuncts to metformin for the treatment of adults with type 2 diabetes. METHODS Participants (n = 386) were randomized to receive bexagliflozin (20 mg) or sitagliptin (100 mg) in addition to their existing doses of metformin. The primary endpoint was the non-inferiority of bexagliflozin to sitagliptin for change in HbA1c from baseline to week 24. Changes from baseline to week 24 in fasting plasma glucose (FPG), body mass (in subjects with baseline body mass index ≥25 kg m-2 ) and systolic blood pressure (SBP) were secondary endpoints. RESULTS The mean change from baseline to week 24 in HbA1c was -0.74 (95% CI -0.86%, -0.62%) in the bexagliflozin arm and -0.82% (95% CI -0.93%, -0.71%) in the sitagliptin arm, establishing non-inferiority. The changes from baseline FPG, body mass and SBP were -1.82 mmol L-1 , -3.35 kg and -4.23 mmHg in the bexagliflozin arm and -1.45 mmol L-1 , -0.81 kg and -1.90 mmHg in the sitagliptin arm, respectively. These differences were significant for the first two measures (one-sided P = 0.0123, P < 0.0001 and P = 0.0276, respectively.) Adverse events were experienced by 47.1% of subjects in the bexagliflozin arm and 56.0% of subjects taking sitagliptin. Serious adverse events affected 3.7% of subjects in the bexagliflozin arm and 2.1% of subjects in the sitagliptin arm. CONCLUSIONS Bexagliflozin was non-inferior to sitagliptin and provided benefits over sitagliptin in FPG and body mass. Adverse event incidences in the two arms were similar.
-
7.
BMI is Associated with the Willingness to Record Diet with a Mobile Food Record among Adults Participating in Dietary Interventions.
Kerr, DA, Dhaliwal, SS, Pollard, CM, Norman, R, Wright, JL, Harray, AJ, Shoneye, CL, Solah, VA, Hunt, WJ, Zhu, F, et al
Nutrients. 2017;(3)
Abstract
Image-based dietary assessment methods have the potential to address respondent burden and improve engagement in the task of recording for dietary interventions. The aim of this study was to assess factors associated with the willingness of adults to take images of food and beverages using a mobile food record (mFR) application. A combined sample of 212 young adults and 73 overweight and obese adults completed a 4-day mobile food record on two occasions and a follow-up usability questionnaire. About 74% of participants stated they would record using the mFR for a longer period compared with a written record (29.4 ± 69.3 vs. 16.1 ± 42.6 days respectively; p < 0.0005). Multivariable logistic regression was used to identify those who were more likely to record mFR in the top tertile (≥14 days). After adjusting for age and gender, those with a BMI ≥ 25 were 1.68 times more likely (Odds Ratio 95% Confidence Interval: 1.02-2.77) than those with BMI < 25 to state a willingness to record with the mFR for ≥ 14 days. The greater willingness of overweight and obese individuals to record dietary intake using an mFR needs further examination to determine if this translates to more accurate estimates of energy intake.
-
8.
A Randomized Crossover Trial of Dietary Sodium Restriction in Stage 3-4 CKD.
Saran, R, Padilla, RL, Gillespie, BW, Heung, M, Hummel, SL, Derebail, VK, Pitt, B, Levin, NW, Zhu, F, Abbas, SR, et al
Clinical journal of the American Society of Nephrology : CJASN. 2017;(3):399-407
-
-
Free full text
-
Abstract
BACKGROUND AND OBJECTIVES Patients with chronic kidney disease (CKD) are often volume expanded and hypertensive. Few controlled studies have assessed the effects of a sodium-restricted diet (SRD) in CKD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS We conducted a randomized crossover trial to evaluate the effect of SRD (target <2 g sodium per day) versus usual diet on hydration status (by bioelectrical impedance spectroscopy) and blood pressure (BP) between May of 2009 and May of 2013. A total of 58 adults with stage 3-4 CKD were enrolled from two academic sites: University of Michigan (n=37) and University of North Carolina at Chapel Hill (n=21); 60% were men, 43% were diabetic, 93% were hypertensive, and mean age was 61 years. Participants followed SRD or usual diet for 4 weeks, followed by a 2-week washout period and a 4-week crossover phase. During the SRD, dieticians provided counseling every 2 weeks, using motivational interviewing techniques. RESULTS Whole-body extracellular volume and calf intracellular volume decreased by 1.02 L (95% confidence interval [95% CI], -1.48 to -0.56; P<0.001) and -0.06 L (95% CI, -0.12 to -0.01; P=0.02), respectively, implying decreased fluid content on the SRD compared with usual diet. Significant reductions in urinary sodium (-57.3 mEq/24 h; 95% CI, -81.8 to -32.9), weight (-2.3 kg; 95% CI, -3.2 to -1.5), and 24-hour systolic BP (-10.8 mmHg; 95% CI, -17.0 to -4.6) were also observed (all P<0.01). Albumin-to-creatinine ratio did not change significantly and mean serum creatinine increased slightly (0.1 mg/dl; 95% CI, -0.01 to 0.2; P=0.06). No period or carryover effects were observed. Results were similar when analyzed from phase 1 only before crossover, although P values were modestly larger because of the loss of power. CONCLUSIONS In this randomized crossover trial, implementation of SRD in patients with CKD stage 3-4 resulted in clinically and statistically significant improvement in BP and hydration status. This simple dietary intervention merits a larger trial in CKD to evaluate effects on major clinical outcomes.
-
9.
[Xinfeng capsule improves hypercoagulative state by inhibiting miR-155/NF-κB signaling pathway in patients with active ankylosing spondylitis].
Fang, L, Liu, J, Wan, L, Zhu, F, Tan, B, Zhang, P
Xi bao yu fen zi mian yi xue za zhi = Chinese journal of cellular and molecular immunology. 2016;(8):1094-8
Abstract
Objective To observe the effect of Xinfeng capsule (XFC) on miR-155, nuclear factor kappa B (NF-κB) signal pathway, and indexes related to hypercoagulative state in patients with active ankylosing spondylitis (AS), and investigate the possible mechanism. Methods Fifty-six cases in active AS were randomly divided into XFC group and sulfasalazine (SASP) group. All cases in the XFC group took three capsules three times daily for twelve consecutive weeks. The ones in the SASP group took four tablets two times daily for twelve consecutive weeks. The expression of miR-155 was detected by real-time PCR. The mRNA expressions of nuclear factor κB activator 1(Act1), NF-κB inhibitor-alpha (IκBα), inhibitor of kappa-B kinase beta (IKKβ), NF-κB p65, and NF-κB p50 were tested by reverse transcription PCR (RT-PCR). Meanwhile, the protein expressions of NF-κB P65 and NF-κB P50 were determined by Western blotting. Tumor necrosis factor-alpha (TNF-α), interleukin (IL)-4, IL-10, IL-17, thromboxane B2 (TXB2), 6-ketone-prostaglandin F1 (6-keto-PGF1), platelet granular membrane protein 140 (GMP140), platelet activation factor (PAF), and plasminogen activator inhibitor-2 (PAI-2) were determined by ELISA. Clinical efficacy was evaluated in the two groups. Results Compared with the SASP group, 50% Bath ankylosing spondylitis disease activity index (BASDAI50) was significantly higher in the XFC group. Compared with the SASP group after treatment, platelet (PLT), fibrinogen (FBG) and D-D dimer (D-D), TXB2, GMP140, PAF, PAI-2, IL-17, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), visual analog scale (VAS), BASDAI, BASFI, and BAS-G were reduced more obviously in the XFC group after treatment; meanwhile, 6-keto-PGF1, IL-4, and IL-10 significantly increased. Compared with the SASP group after treatment, the expressions of IKKβ mRNA, IκBα mRNA, NF-κB p65 mRNA, NF-κB p50 mRNA, NF-κB P65 protein, NF-κB P50 protein, and miR-155 were lower in the XFC group after treatment. Conclusion XFC could effectively improve hypercoagulative state in active AS patients. The potential mechanism may be associated with the inhibition of miR-155 and NF-κB signal pathway.
-
10.
Children With Intracranial Arachnoid Cysts: Classification and Treatment.
Tan, Z, Li, Y, Zhu, F, Zang, D, Zhao, C, Li, C, Tong, D, Zhang, H, Chen, Q
Medicine. 2015;(44):e1749
-
-
Free full text
-
Abstract
We performed a dynamic study of arachnoid cysts (ACs) using magnetic resonance cisternography (MRC) and proposed a classification of ACs.Twenty-three suitable patients in our hospital entered into this study according to our inclusion criteria. MRC images were collected in all the subjects at 1 and 24 hours after the administration of intrathecal gadolinium-diethylenetriamine penta-acetic acid (Gd-DTPA). We allocate the enrolled patients into 2 groups, MRC group and surgery group. The MRC results were considered before treatment in 1 group (MRC group, 13 patients), whereas another group was surgically treated without considering the MRC results (surgery group, 10 patients). We calculated the enhanced area of cyst using modified MacDonald Criteria from the images and measured the surrounding subarachnoid area as the reference.We found that it was practically useful to quantify 3 types of ACs, complete communicating, incomplete communicating, and noncommunicating, according to MRC results in this study. All the subjects in both groups are closely observed before the treatment and the follow-up using the MRI examination. In the surgery group, 5 patients were found that the area of cysts shrank in the follow-up stage. However, there was no significant difference in the percentage shrinkage area between the 2 groups.We concluded that MRC with Gd-DTPA as a contrast agent is of significant clinical value for the diagnosis and treatment of children with intracranial ACs. This classification based on dynamic MRC is useful for making surgical recommendations.