A Randomized Clinical Trial
AUDIENCE: Internal Medicine
KEY FINDINGS: In this randomized clinical trial, eTRE was more effective for losing weight and improving diastolic blood pressure and mood than eating over a window of 12 or more hours at 14 weeks.
BACKGROUND: It is unclear how effective intermittent fasting is for losing weight and body fat, and the effects may depend on the timing of the eating window. This randomized trial compared time-restricted eating (TRE) with eating over a period of 12 or more hours while matching weight-loss counseling across groups. Aim of this study is to determine whether practicing TRE by eating early in the day (eTRE) is more effective for weight loss, fat loss, and cardiometabolic health than eating over a period of 12 or more hours.
DETAILS: The study was a 14-week, parallel-arm, randomized clinical trial conducted between August 2018 and April 2020. Participants were adults aged 25 to 75 years with obesity and who received weight-loss treatment through the Weight Loss Medicine Clinic at the University of Alabama at Birmingham Hospital. All participants received weight-loss treatment (energy restriction [ER]) and were randomized to eTRE plus ER (8-hour eating window from 7:00 to 15:00) or control eating (CON) plus ER (>=12-hour window). The co–primary outcomes were weight loss and fat loss. Secondary outcomes included blood pressure, heart rate, glucose levels, insulin levels, and plasma lipid levels. Ninety participants were enrolled (mean [SD] body mass index, 39.6 [6.7]; age, 43  years; 72 [80%] female). The eTRE+ER group adhered 6.0 (0.8) days per week. The eTRE+ER intervention was more effective for losing weight (-2.3 kg; 95% CI, -3.7 to -0.9 kg; P = .002) but did not affect body fat (-1.4 kg; 95% CI, -2.9 to 0.2 kg; P = .09) or the ratio of fat loss to weight loss (-4.2%; 95% CI, -14.9 to 6.5%; P = .43). The effects of eTRE+ER were equivalent to reducing calorie intake by an additional 214 kcal/d. The eTRE+ER intervention also improved diastolic blood pressure (-4 mm Hg; 95% CI, -8 to 0 mm Hg; P = .04) and mood disturbances, including fatigue-inertia, vigor-activity, and depression-dejection. All other cardiometabolic risk factors, food intake, physical activity, and sleep outcomes were similar between groups. In a secondary analysis of 59 completers, eTRE+ER was also more effective for losing body fat and trunk fat than CON+ER.
Copyright © American Medical Association. All Rights Reserved.
Source: Jamshed, H. Steger, F. L., Bryn, D. R., et al. (2022). Effectiveness of Early Time-Restricted Eating for Weight Loss, Fat Loss, and Cardiometabolic Health in Adults With Obesity: A Randomized Clinical Trial. JAMA Intern Med.. Published: August 8, 2022. DOI: 10.1001/jamainternmed.2022.3050.
A Nationwide Emulation Trial
AUDIENCE: Internal Medicine, Oncology, Ob/Gyn
KEY FINDINGS: Continuation of anti-TNF after 24 weeks of pregnancy appears beneficial regarding IBD activity and prematurity, while not affecting neonatal outcomes and serious infections in the offspring.
BACKGROUND: Continuation of biologics for inflammatory disorders during pregnancy is still a difficult decision. Many women with inflammatory bowel diseases (IBDs) stop anti-tumor necrosis factor (anti-TNF) treatment after 24 weeks.
DETAILS: Occurrence of maternal IBD relapse up to 6 months after pregnancy, adverse pregnancy outcomes, and serious infections in the offspring during the first 5 years of life was compared according to anti-TNF continuation after 24 weeks of pregnancy using inverse probability-weighted marginal models. A total of 5293 pregnancies were included; among them, anti-TNF treatment was discontinued before 24 weeks for 2890 and continued beyond 24 weeks for 2403. Continuation of anti-TNF was associated with decreased frequencies of maternal IBD relapse (35.8% vs. 39.0%; adjusted risk ratio [aRR], 0.93 [95% CI, 0.86 to 0.99]) and prematurity (7.6% vs. 8.9%; aRR, 0.82 [CI, 0.68 to 0.99]). No difference according to anti-TNF continuation was found regarding stillbirths (0.4% vs. 0.2%; aRR, 2.16 [CI, 0.64 to 7.81]), small weight for gestational age births (13.1% vs. 12.9%; aRR, 1.01 [CI, 0.88 to 1.17]), and serious infections in the offspring (54.2 vs. 50.2 per 1000 person-years; adjusted hazard ratio, 1.08 [CI, 0.94 to 1.25]).
Copyright © American College of Physicians. All Rights Reserved.
Source: Meyer, A., Neumann, A., Drouin, J., et al. (2022). Benefits and Risks Associated With Continuation of Anti-Tumor Necrosis Factor After 24 Weeks of Pregnancy in Women With Inflammatory Bowel Disease. Annals of Internal Medicine. Published: September 27, 2022. DOI: 10.7326/M22-0819.
A Cohort Study
AUDIENCE: Gastroenterology, Internal Medicine
KEY FINDINGS: In this retrospective, age-stratified analysis, it was reported that persistent-positive serology may be associated with the risk of hypothyroidism among the pediatric population. Prospective cohorts are needed to validate our findings.
BACKGROUND: During the study whether persistent-positive celiac serology is associated with the risk of hypothyroidism was evaluated.
DETAILS: Extracted a cohort of subjects aged 1-80 years with a positive IgA anti-tissue transglutaminase between January 1, 2008, and December 31, 2012, and a repeat anti-tissue transglutaminase test within 6-36 months from a large population-based electronic medical record database. Based on serology tests, categorized the pediatric (age <21 years) and adult cohorts into normalized or persistent-positive serology groups. All subjects were followed up for incident diagnosis of hypothyroidism from the last serology date up to December 31, 2017. Hazard ratio (HR) along 95% confidence intervals (CIs) were prepared to evaluate the association of celiac serology group with a diagnosis of hypothyroidism, crude, and adjusted for age, sex, and diagnosis of type 1 diabetes mellitus. Among the pediatric cohort (n = 2,687), during a median follow-up of 64 months (interquartile range 48-80), 2.3% (16/681) of the persistent-positive serology group and 1.0% (20/2,006) of the normalized serology group developed hypothyroidism (HR 2.07 [95% CI 1.07-4.44], adjHR 1.77 [95% CI 0.91-3.46]). The rate among the pediatric cohort with an established diagnosis of celiac disease was 3.4% (10/486) vs 1.0% (5/481), HR 2.83 (0.96-8.32). In the adult cohort (n = 1,286), 4.5% (20/442) of the persistent-positive group and 3.9% (33/811) of the normalized serology group developed hypothyroidism (HR 1.13 [95% CI 0.65-1.97]).
Copyright © The American College of Gastroenterology. All rights reserved.
Source: Golan, M. A., Feldman, B., Ollech, J. E., et al. (2022). Association of Celiac Serology Normalization With the Risk of Hypothyroidism: A Cohort Study. American Journal of Gastroenterology. 2022; 117(9): 1428-1436, 2022Published: September 2022. DOI: 10.14309/ajg.0000000000001872.
AUDIENCE: Endocrinology, Family Medicine
KEY FINDINGS: Patients with diabetes with a Charcot foot have an increased risk of fractures and osteoporosis compared with patients with diabetes without a Charcot foot.
BACKGROUND: Charcot foot is a serious complication of diabetes, with degeneration of the bones and joints in the foot and ankle. It is unknown whether patients with diabetes with a Charcot foot have an increased risk of osteoporosis and fractures. The aim of this study was to investigate whether patients with diabetes with a Charcot foot have an increased risk of fracture and/or osteoporosis compared with patients with diabetes without Charcot foot.
DETAILS: A Danish register-based, nationwide population-based matched cohort study was conducted. During 1995-2018, identified 1,602 patients with diabetes with Charcot foot and matched them on sex and date of diagnosis of diabetes with 16,296 patients with diabetes without Charcot foot. Used logistic regression to estimate odds ratios (ORs) with 95% CIs for fracture and osteoporosis. Information about exposure, outcome, and comorbidities was retrieved from the Danish National Patient Register. Diabetes patients with Charcot foot had higher risk of fractures compared with those without Charcot foot (i.e., ORs for any fracture, lower-leg fracture, foot fracture, and osteoporotic fracture were 1.8 [95% CI 1.6-2.0], 2.4 [2.0-2.8], 2.9 [2.6-3.3], and 1.3 [1.1-1.4], respectively). Furthermore, patients with diabetes with Charcot foot had higher risk of osteoporosis compared with the patients without Charcot foot, with an OR of 1.3 (95% CI 1.1-1.5).
Copyright © American Diabetes Association. All rights reserved.
Source: Rabe, O. C., Winther-Jensen, M., Allin, K. H., et al. (2022). Fractures and Osteoporosis in Patients With Diabetes With Charcot Foot. Diabetes Care . 2022; 44(9): 2033-2038. Published: September, 2022. DOI: 10.2337/dc21-0369.
AUDIENCE: Cardiology, Emergency Medicine
KEY FINDINGS: In conclusion, an increase in CIMT seen with advanced age and severe hypercholesterolemia was halted with lipoprotein apheresis with an estimated annual rate of change in mean common CIMT of -4 µm/y and maximum CIMT of -3 µm/y.
BACKGROUND: The extent of intervention effects on carotid intima-media thickness (CIMT) can predict the degree of atherosclerotic cardiovascular risk-reduction. It was hypothesized that regular lipoprotein apheresis over the course of 10 years might slow down progression of CIMT in patients with severe hypercholesterolemia.
DETAILS: This case series describes 10 Caucasian patients (mean age 60 ± 9 years, 70% female, 80% statin intolerant) with a severe hypercholesterolemia phenotype treated with lipoprotein apheresis between 2005 and 2020 (mean duration, 10 ± 4 years). The median pretreatment low-density lipoprotein cholesterol (LDL-C) level was 214 mg/100 ml (95% confidence interval, 145 to 248), lipoprotein(a) (Lp[a]), 26 mg/100 ml (15 to 109; 40% with Lp(a)>60 mg/100 ml). Three patients were diagnosed with a monogenic cause. The baseline mean CIMT was 850 ± 170 µm, and maximum CIMT was 1,040 ± 220 µm across the age range of 46 to 70 years. Acute effects of lipoprotein apheresis determined as a difference before and immediately after the procedure were estimated as a median of 72 ± 8% and 75 ± 7% reduction in the LDL-C and Lp(a) levels, respectively. Using the imputed trajectories, period-specific on-treatment time-weighted averages for LDL-C and Lp(a) were 141 mg/100 ml (interquartile range, 89 to 152; 38% reduction from the baseline) and 24 mg/100 ml (interquartile range, 12 to 119; 19% reduction from baseline), respectively. The number of patients with CIMT above their "vascular age" decreased from 80% to 30% over the treatment course.
Copyright © Elsevier Inc. All rights reserved.
Source: Safarova, M. S., Nugent, A. K., Gorby L., et al. (2022). Effect of Lipoprotein Apheresis on Progression of Carotid Intima-Media Thickness in Patients with Severe Hypercholesterolemia. Am J Cardiol.. 2022; 177: 22-27. Published: August 15, 2022. DOI: 10.1016/j.amjcard.2022.05.002.
AUDIENCE: Ophthalmology, Family Medicine
KEY FINDINGS: Adherence to frequent postoperative eye drops was high and can be successfully monitored remotely. Surgical success was greater among eyes with nearly ideal adherence and was poorer in older persons and those with more advanced glaucoma.
BACKGROUND: Objective of this study was to compare electronically measured adherence with topical corticosteroid (CS) drops with outcomes of glaucoma surgery. This prospective cohort study included eyes undergoing surgery from August 2019 to January 2021 and followed for up to 1 year.
DETAILS: All patients were recruited from the Glaucoma Center of Excellence at the Wilmer Eye Institute, Johns Hopkins. Eligible patients had primary open-angle or angle-closure glaucoma, were aged >=18 years, and underwent trabeculectomy (with or without cataract surgery) or tube-shunt implantation. All patients were recruited from the Glaucoma Center of Excellence at the Wilmer Eye Institute, Johns Hopkins. Eligible patients had primary open-angle or angle-closure glaucoma, were aged >=18 years, and underwent trabeculectomy (with or without cataract surgery) or tube-shunt implantation. Among 90 patients, adherence was 89.7% ± 13.7% overall and 80.9% ± 15.8% during dosing every 2 hours. Target IOP was achieved at the final visit (6 months or 1 year) in 81% (59/73) without reoperation. Eyes with a higher ratio of drops taken versus prescribed were significantly more likely to achieve target IOP at 6 months/1 year (P = 0.05). Total adherence was better in younger persons, eyes with less field loss, and patients of one particular surgeon (P < 0.03). Percent adherence during dosing every 2 hours was higher in eyes with higher target IOP (P = 0.01). No adherence outcome was significantly related to race, sex, bleb morphology, postoperative pain, or postoperative anterior chamber inflammation. Adherence values did not significantly correlate with adherence questionnaire data (predicted mean = 78% ± 17%, actual mean = 91% ± 13% adherent, P < 0.001).
Copyright © The American Academy of Ophthalmology. All rights reserved.
Source: McGlumphy, E. J., Doto, N. O., Johnson, T. V., et al. (2022). Electronically Monitored Corticosteroid Eye Drop Adherence after Trabeculectomy Compared to Surgical Success. Ophthalmology Glaucoma. 2022; 5(4): 379-387. Published: July 1, 2022. DOI: 10.1016/j.ogla.2021.12.007.