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Effectiveness of restricted diet with a plate in patients with type 2 diabetes: A randomized controlled trial.
Zhang, Y, Han, H, Chu, L
Primary care diabetes. 2022;(3):368-374
Abstract
BACKGROUND In view of the complexity of dietary and nutritional education for most patients with type 2 diabetes mellitus (T2DM), a simplified approach called the "restricted diet with a plate" or "plate model" is recommended. PURPOSE To evaluate whether the plate model can effectively improve glycemic control and cardiovascular risk markers in type 2 diabetes mellitus (T2DM), while reducing the time devoted to education and avoiding weight gain. METHODS The study was a randomized, multicenter, controlled study, conducted between October 2018 and October 2019, among patients with T2DM living in Nanjing. The study included 419 participants who were randomly divided into a plate group and a counting group. The plate model included three components: a low-literacy, color leaflet containing the explanation and composition of the plate model, health education, and medical visits. Patients in the counting group received health education, group medical visits, and a paper booklet containing traditional carbohydrate counting education. Primary outcomes were glycemic control and weight. RESULTS Participants in the plate model reduced HbA1c by 0.7% in the first three months, and reduced to a greater extent at six months (1.44%), but this was not sustained, and HbA1c increased slightly over the following six months. Fasting plasma glucose (FPG) and 2-h postprandial glucose (2hPG) values were significantly reduced at the endpoint in the plate model (9.25 ± 1.72% vs. 7.44 ± 0.88%, P = 0.008; 12.07 ± 2.94 vs. 8.35 ± 1.99%; P = 0.004); however, the 2hPG values decreased most significantly. Total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) levels decreased significantly in the plate group, which occurred at six months and lasted for 12 months. In the first three months, the average weight loss in the plate group was 1.2 kg/month (95% CI 0.92-1.48), and in the fourth to twelfth months, the average weight gain was 0.21 kg/month (95% CI 0.08-0.34). There was significant difference in education time between the groups (17.3 ± 4.42 vs. 38.6 ± 12.63; P < 0.001). CONCLUSIONS The plate model is at least as effective as the counting model over the short term for glycemic control and perhaps even better for weight and lipid control. Plate model has the potential to improve education of those with low health literacy by reducing reading demands.
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Impact of hemodialysis and post-dialysis period on granular activity levels.
Larkin, JW, Han, M, Han, H, Guedes, MH, Gonçalves, PB, Poli-de-Figueiredo, CE, Cuvello-Neto, AL, Barra, ABL, de Moraes, TP, Usvyat, LA, et al
BMC nephrology. 2020;(1):197
Abstract
BACKGROUND Physical activity (PA) is typically lower on hemodialysis (HD) days. Albeit intradialytic inactivity is expected, it is unknown whether recovery after HD contributes to low PA. We investigated the impact of HD and post-HD period on granular PA relative to HD timing. METHODS We used baseline data from the HDFIT trial conducted from August 2016 to October 2017. Accelerometry measured PA over 1 week in patients who received thrice-weekly high-flux HD (vintage 3 to 24 months), were clinically stable, and had no ambulatory limitations. PA was assessed on HD days (0 to ≤24 h after start HD), first non-HD days (> 24 to ≤48 h after start HD) and second non-HD day (> 48 to ≤72 h after start HD). PA was recorded in blocks/slices: 4 h during HD, 0 to ≤2 h post-HD (30 min slices), and > 2 to ≤20 h post-HD (4.5 h slices). Blocks/slices of PA were captured at concurrent/parallel times on first/second non-HD days compared to HD days. RESULTS Among 195 patients (mean age 53 ± 15 years, 71% male), step counts per 24-h were 3919 ± 2899 on HD days, 5308 ± 3131 on first non-HD days (p < 0.001), and 4926 ± 3413 on second non-HD days (p = 0.032). During concurrent/parallel times to HD on first and second non-HD days, patients took 1308 and 1128 more steps (both p < 0.001). Patients took 276 more steps and had highest rates of steps/hour 2-h post-HD versus same times on first non-HD days (all p < 0.05). Consistent findings were observed on second non-HD days. CONCLUSIONS PA was higher within 2-h of HD versus same times on non-HD days. Lower PA on HD days was attributable to intradialytic inactivity. The established PA profiles are of importance to the design and development of exercise programs that aim to increase activity during and between HD treatments. TRIAL REGISTRATION HDFIT was prospectively registered 20 April 2016 on ClinicalTrials.gov (NCT02787161).
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Biportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trial.
Park, SM, Park, J, Jang, HS, Heo, YW, Han, H, Kim, HJ, Chang, BS, Lee, CK, Yeom, JS
The spine journal : official journal of the North American Spine Society. 2020;(2):156-165
Abstract
BACKGROUND CONTEXT Biportal endoscopic decompressive laminectomy is a widely performed procedure and shows acceptable clinical outcomes. However, the evidence regarding the advantages of biportal endoscopic surgery is weak, a randomized controlled trial is therefore warranted. PURPOSE To compare the clinical efficacies of biportal endoscopic and microscopic decompressive laminectomy in patients with lumbar spinal stenosis. STUDY DESIGN Randomized controlled trial. PATIENT SAMPLE Sixty-four participants suffering from low back and leg pain with single-level lumbar spinal stenosis who required decompressive laminectomy. OUTCOME MEASURES Outcomes were assessed with the use of patient-reported outcome measures, visual analog scale (VAS) score for low back and lower extremity radiating pain, Oswestry disability index (ODI), European Quality of Life-5 Dimensions (EQ-5D) score, and painDETECT for neuropathic pain. Surgery-related outcomes including operation time, length of hospital stay, postoperative drainage, and serum creatine phosphokinase were evaluated. Perioperative (<30 days) and late (1-12 months) complications were also noted. METHODS All participants were randomly assigned in a 1:1 ratio to undergo biportal endoscopic or microscopic decompressive laminectomy. The primary outcome was the ODI score at 12 months after surgery based on a modified intention-to-treat strategy. The secondary outcomes included VAS score for low back and lower extremity radiating pain, ODI scores, EQ-5D score, and painDETECT score. There were no sources of funding and no conflicts of interest associated with this study. RESULTS There was no significant difference between groups in the mean ODI score at 12 months after surgery (30 in the microscopy vs. 29 in the biportal endoscopy group, p=.635). There were also no significant differences in low back and lower extremity pain VAS scores, ODI, EQ-5D scores, and painDETECT scores at the 3-, 6-, or 12-month follow-up. Operation time, length of hospital stay, serum creatine phosphokinase, and perioperative complications, such as durotomies and symptomatic hematoma, showed no significant differences between the groups; however, one participant underwent additional revision surgery 9 months after the index surgery in the microscopy group. CONCLUSIONS Despite the study design limitation of relatively short duration of follow-up, this trial suggests that biportal endoscopic decompressive laminectomy is an alternative to and offers similar clinical outcomes as microscopic open surgery in patients with symptomatic lumbar spinal stenosis.
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Significant improvement in cardiometabolic health in healthy nonobese individuals during caloric restriction-induced weight loss and weight loss maintenance.
Most, J, Gilmore, LA, Smith, SR, Han, H, Ravussin, E, Redman, LM
American journal of physiology. Endocrinology and metabolism. 2018;(4):E396-E405
Abstract
Calorie restriction (CR) triggers benefits for healthspan including decreased risk of cardiometabolic disease (CVD). In an ancillary study to CALERIE 2, a 24-mo 25% CR study, we assessed the cardiometabolic effects of CR in 53 healthy, nonobese (BMI: 22-28 kg/m2) men ( n = 17) and women ( n = 36). The aim of this study was to investigate whether CR can reduce risk factors for CVD and insulin resistance in nonobese humans and, moreover, to assess whether improvements are exclusive to a period of weight loss or continue during weight maintenance. According to the energy balance method, the 25% CR intervention ( n = 34) produced 16.5 ± 1.5% (mean ± SE) and 14.8 ± 1.5% CR after 12 and 24 mo (M12, M24), resulting in significant weight loss (M12 -9 ± 0.5 kg, M24 -9 ± 0.5 kg, P < 0.001). Weight was maintained in the group that continued their habitual diet ad libitum (AL, n = 19). In comparison to AL, 24 mo of CR decreased visceral (-0.5 ± 0.01 kg, P < 0.0001) and subcutaneous abdominal adipose tissue (-1.9 ± 0.2kg, P < 0.001) as well as intramyocellular lipid content (-0.11 ± 0.05%, P = 0.031). Furthermore, CR decreased blood pressure (SBP -8 ± 3 mmHg, P = 0.005; DBP -6 ± 2 mmHg, P < 0.001), total cholesterol (-13.6 ± 5.3 mg/dl, P = 0.001), and LDL-cholesterol (-12.9 ± 4.4 mg/dl, P = 0.005), and the 10-yr risk of CVD-disease was reduced by 30%. Homeostasis model assessment of insulin resistance (HOMA-IR) decreased during weight loss in the CR group (-0.46 ± 0.15, P = 0.003), but this decrease was not maintained during weight maintenance (-0.11 ± 0.15, P = 0.458). In conclusion, sustained CR in healthy, nonobese individuals is beneficial in improving risk factors for cardiovascular and metabolic disease such as visceral adipose tissue mass, ectopic lipid accumulation, blood pressure, and lipid profile, whereas improvements in insulin sensitivity were only transient.
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Instant Oatmeal Increases Satiety and Reduces Energy Intake Compared to a Ready-to-Eat Oat-Based Breakfast Cereal: A Randomized Crossover Trial.
Rebello, CJ, Johnson, WD, Martin, CK, Han, H, Chu, YF, Bordenave, N, van Klinken, BJ, O'Shea, M, Greenway, FL
Journal of the American College of Nutrition. 2016;(1):41-9
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Abstract
BACKGROUND Foods that enhance satiety can help consumers to resist environmental cues to eat and help adherence to calorie restriction. The objective of this study was to compare the effect of 2 oat-based breakfast cereals on appetite, satiety, and food intake. METHODS Forty-eight healthy individuals, 18 years of age or older, were enrolled in a randomized, crossover trial. Subjects consumed isocaloric servings of either oatmeal or an oat-based ready-to-eat breakfast cereal (RTEC) in random order at least a week apart. Visual analogue scales measuring appetite and satiety were completed before breakfast and throughout the morning. Lunch was served 4 hours after breakfast. The physicochemical properties of oat soluble fiber (β-glucan) were determined. Appetite and satiety responses were analyzed by area under the curve. Food intake and β-glucan properties were analyzed using t tests. RESULTS Oatmeal increased fullness (p = 0.001) and reduced hunger (p = 0.005), desire to eat (p = 0.001), and prospective intake (p = 0.006) more than the RTEC. Energy intake at lunch was lower after eating oatmeal compared to the RTEC (p = 0.012). Oatmeal had higher viscosity (p = 0.03), β-glucan content, molecular weight (p < 0.001), and radius of gyration (p < 0.001) than the RTEC. CONCLUSIONS Oatmeal suppresses appetite, increases satiety, and reduces energy intake compared to the RTEC. The physicochemical properties of β-glucan and sufficient hydration of oats are important factors affecting satiety and subsequent energy intake.
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Efficacy of SmartLoss, a smartphone-based weight loss intervention: results from a randomized controlled trial.
Martin, CK, Miller, AC, Thomas, DM, Champagne, CM, Han, H, Church, T
Obesity (Silver Spring, Md.). 2015;(5):935-42
Abstract
OBJECTIVE Test the efficacy of SmartLoss, a smartphone-based weight loss intervention, in a pilot study. DESIGN AND METHODS A 12-week randomized controlled trial. Adults (25 ≤ BMI ≤ 35 kg/m2) were randomized to SmartLoss (n = 20) or an attention-matched Health Education control group (n = 20). SmartLoss participants were prescribed a 1,200 to 1,400 kcal/d diet and were provided with a smartphone, body weight scale, and accelerometer that wirelessly transmitted body weight and step data to a website. In the SmartLoss Group, mathematical models were used to quantify dietary adherence based on body weight and counselors remotely delivered treatment recommendations based on these objective data. The Health Education group received health tips via smartphone. A mixed model determined if change in weight and other endpoints differed between the groups (baseline was a covariate). RESULTS The sample was 82.5% female. Mean ± SD baseline age, weight (kg), and BMI were 44.4 ± 11.8 years, 80.3 ± 11.5 kg, and 29.8 ± 2.9 kg/m2, respectively. One participant was lost to follow-up in each group before week 4. Weight loss was significantly (P < 0.001) larger in the SmartLoss (least squares mean ± SEM: -9.4 ± 0.5%) compared with the Health Education group (-0.6 ± 0.5%). CONCLUSIONS SmartLoss efficaciously promote clinically meaningful weight loss compared with an attention-matched control group. Smartphone-based interventions might prove useful in intervention dissemination.
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Comparison of the pharmacokinetics and tolerability of HCP1004 (a fixed-dose combination of naproxen and esomeprazole strontium) and VIMOVO® (a marketed fixed-dose combination of naproxen and esomeprazole magnesium) in healthy volunteers.
Choi, Y, Han, H, Shin, D, Lim, KS, Yu, KS
Drug design, development and therapy. 2015;:4127-35
Abstract
BACKGROUND HCP1004 is a newly developed fixed-dose combination of naproxen (500 mg) and esomeprazole strontium (20 mg) that is used in the treatment of rheumatic diseases and can reduce the risk of nonsteroidal anti-inflammatory drug-associated ulcers. The aim of this study was to evaluate the pharmacokinetics (PK) and safety of HCP1004 compared to VIMOVO(®) (a marketed fixed-dose combination of naproxen and esomeprazole magnesium). SUBJECTS AND METHODS An open-label, randomized, two-treatment, two-sequence crossover, single-dose clinical study was conducted in 70 healthy volunteers. In each period, a reference (VIMOVO(®)) or test (HCP1004) drug was administered orally, and serial blood samples for PK analysis were collected up to 72 hours after dosing. To evaluate the PK profiles, the maximum plasma concentration (Cmax) and the area under the concentration-time curve from 0 to the last measurable time (AUC0-t) were estimated using a noncompartmental method. Safety profiles were evaluated throughout the study. RESULTS Sixty-six of the 70 subjects completed the study. The Cmax (mean ± standard deviation) and AUC0-t (mean ± standard deviation) for naproxen in HCP1004 were 61.67 ± 15.16 µg/mL and 1,206.52 ± 166.46 h · µg/mL, respectively; in VIMOVO(®); these values were 61.85 ± 14.54 µg/mL and 1,211.44 ± 170.01 h · µg/mL, respectively. The Cmax and AUC0-t for esomeprazole in HCP1004 were 658.21 ± 510.91 ng/mL and 1,109.11 ± 1,111.59 h · ng/mL, respectively; for VIMOVO(®), these values were 595.09 ± 364.23 ng/mL and 1,015.12 ± 952.98 h · ng/mL, respectively. The geometric mean ratios and 90% confidence intervals (CIs) (HCP1004 to VIMOVO(®)) of the Cmax and AUC0-t of naproxen were 0.99 (0.94-1.06) and 1.00 (0.98-1.01), respectively. For esomeprazole, the geometric mean ratios (90% CI) for the Cmax and AUC0-t were 0.99 (0.82-1.18) and 1.04 (0.91-1.18), respectively. The overall results of the safety assessment showed no clinically significant issues for either treatment. CONCLUSION The PK of HCP1004 500/20 mg was comparable to that of VIMOVO(®) 500/20 mg for both naproxen and esomeprazole after a single oral dose. Both drugs were well-tolerated without any safety issues.
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Effect of Extended-Release Niacin on Carotid Intima Media Thickness, Reactive Hyperemia, and Endothelial Progenitor Cell Mobilization: Insights From the Atherosclerosis Lesion Progression Intervention Using Niacin Extended Release in Saphenous Vein Grafts (ALPINE-SVG) Pilot Trial.
Guerra, A, Rangan, BV, Coleman, A, Xu, H, Kotsia, A, Christopoulos, G, Sosa, A, Chao, H, Han, H, Abdurrahim, G, et al
The Journal of invasive cardiology. 2015;(12):555-60
Abstract
BACKGROUND Thirty-eight patients with intermediate (30%-60% diameter stenosis) saphenous vein graft lesions were randomized to extended-release niacin (ER-niacin) or placebo for 12 months. We sought to evaluate the impact of ER-niacin on carotid intima media thickness (CIMT), endothelial function, and endothelial progenitor cell (EPC) mobilization. METHODS Carotid B-mode ultrasound was used to image the common and internal carotid arteries, at baseline and at 12 months after enrollment. Reactive hyperemia peripheral arterial tonometry, as assessed with EndoPAT 2000 (Itamar Medical, Inc) and EPC mobilization assessed with flow cytometry, were measured at enrollment, and at 1 and 12 months. RESULTS The baseline clinical characteristics were similar in the two study groups. High-density lipoprotein cholesterol levels tended to increase more in the ER-niacin group (5.9 ± 8.7 mg/dL vs 1.4 ± 7.1 mg/dL; P=.14). Between baseline and 12 months, right common carotid artery (0.96 ± 0.44 mm vs 0.70 ± 0.24 mm; P=.04), and left common carotid artery (0.80 ± 0.30 mm vs 0.70 ± 0.20 mm; P=.08) CIMT tended to decrease in the ER-niacin group, compared with no change in the placebo group. The change in logarithmic reactive hyperemia index between 1 month and 12 months was similar in patients receiving ER-niacin vs placebo (0.003 ± 0.12 vs -0.058 ± 0.12; P=.39), whereas EPC mobilization increased in the ER-niacin group and decreased in the placebo group (8.65 ± 28.41 vs -5.87 ± 30.23 EPC colony forming units/mL of peripheral blood; P=.02). CONCLUSIONS ER-niacin did not have a significant impact on CIMT or endothelial function, but increased EPC mobilization.
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The effect of an egg breakfast on satiety in children and adolescents: a randomized crossover trial.
Liu, AG, Puyau, RS, Han, H, Johnson, WD, Greenway, FL, Dhurandhar, NV
Journal of the American College of Nutrition. 2015;(3):185-90
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Abstract
OBJECTIVE To evaluate the effects of an egg breakfast on lunchtime energy intake in children (age 4-6 years) and adolescents (age 14-17 years). METHODS In 2 randomized crossover trials, participants received either an egg breakfast or an isocaloric bagel breakfast. In both trials, subsequent lunchtime energy intake was the primary outcome. The trial with adolescents also measured each participant's serum ghrelin, serum peptide YY (PYY), and self-assessment of appetite rated using a visual analog scale. RESULTS Lunchtime food intakes after egg and bagel breakfasts were not significantly different for either age group. Visual analog scale ratings of hunger and satiety were also not different between the 2 treatments in adolescents. Consumption of the egg breakfast led to a significant increase in serum PYY levels (p = 0.0001) in adolescents. However, increased levels of PYY were not correlated with reduced food intake. CONCLUSION Short-term food intake in children and adolescents is not differentially altered by an egg breakfast compared to a bagel breakfast.
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Effects of weight gain induced by controlled overfeeding on physical activity.
Apolzan, JW, Bray, GA, Smith, SR, de Jonge, L, Rood, J, Han, H, Redman, LM, Martin, CK
American journal of physiology. Endocrinology and metabolism. 2014;(11):E1030-7
Abstract
It is unclear whether physical activity changes following long-term overfeeding and in response to different dietary protein intakes. Twenty-five (16 males, 9 females) healthy adults (18-35 yr) with BMI ranging from 19 to 30 kg/m(2) enrolled in this inpatient study. In a parallel group design, participants were fed 140% of energy needs, with 5, 15, or 25% of energy from protein, for 56 days. Participants wore an RT3 accelerometer for at least 59 days throughout baseline and during overfeeding and completed 24-h whole room metabolic chamber assessments at baseline and on days 1, 14, and 56 of overfeeding and on day 57, when the baseline energy intake was consumed, to measure percent of time active and spontaneous physical activity (SPA; kcal/day). Changes in activity were also assessed by doubly labeled water (DLW). From accelerometry, vector magnitude (VM), a weight-independent measure of activity, and activity energy expenditure (AEE) increased with weight gain during overfeeding. AEE remained increased after adjusting for changes in body composition. Activity-related energy expenditure (AREE) from DLW and percent activity and SPA in the metabolic chamber increased with overfeeding, but SPA was no longer significant after adjusting for change in body composition. Change in VM and AEE were positively correlated with weight gain; however, change in activity was not affected by protein intake. Overfeeding produces an increase in physical activity and in energy expended in physical activity after adjusting for changes in body composition, suggesting that increased activity in response to weight gain might be one mechanism to support adaptive thermogenesis.