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1.
Lancet Healthy Longev ; 5(5): e314-e325, 2024 May.
Article En | MEDLINE | ID: mdl-38588687

BACKGROUND: Time-restricted eating (TRE) has been suggested to be a simple, feasible, and effective dietary strategy for individuals with overweight or obesity. We aimed to investigate the effects of 3 months of 10-h per-day TRE and 3 months of follow-up on bodyweight and cardiometabolic risk factors in individuals at high risk of type 2 diabetes. METHODS: This was a single-centre, parallel, superiority, open-label randomised controlled clinical trial conducted at Steno Diabetes Center Copenhagen (Denmark). The inclusion criteria were age 30-70 years with either overweight (ie, BMI ≥25 kg/m2) and concomitant prediabetes (ie, glycated haemoglobin [HbA1c] 39-47 mmol/mol) or obesity (ie, BMI ≥30 kg/m2) with or without prediabetes and a habitual self-reported eating window (eating and drinking [except for water]) of 12 h per day or more every day and of 14 h per day or more at least 1 day per week. Individuals were randomly assigned 1:1 to 3 months of habitual living (hereafter referred to as the control group) or TRE, which was a self-selected 10-h per-day eating window placed between 0600 h and 2000 h. Randomisation was done in blocks varying in size and was open for participants and research staff, but outcome assessors were masked during statistical analyses. The randomisation list was generated by an external statistician. The primary outcome was change in bodyweight, assessed after 3 months (12 weeks) of the intervention and after 3 months (13 weeks) of follow-up. Adverse events were reported and registered at study visits or if participants contacted study staff to report events between visits. This trial is registered on ClinicalTrials.gov (NCT03854656). FINDINGS: Between March 12, 2019, and March 2, 2022, 100 participants (66 [66%] were female and 34 [34%] were male; median age 59 years [IQR 52-65]) were enrolled and randomly assigned (50 to each group). Of those 100, 46 (92%) in the TRE group and 46 (92%) in the control group completed the intervention period. After 3 months of the intervention, there was no difference in bodyweight between the TRE group and the control group (-0·8 kg, 95% CI -1·7 to 0·2; p=0·099). Being in the TRE group was not associated with a lower bodyweight compared with the control group after subsequent 3-month follow-up (-0·2 kg, -1·6 to 1·2). In the per-protocol analysis, participants who completed the intervention in the TRE group lost 1·0 kg (-1·9 to -0·0; p=0·040) bodyweight compared with the control group after 3 months of intervention, which was not maintained after the 3-month follow-up period (-0·4 kg, -1·8 to 1·0). During the trial and follow-up period, one participant in the TRE group reported a severe adverse event: development of a subcutaneous nodule and pain when the arm was in use. This side-effect was evaluated to be related to the trial procedures. INTERPRETATION: 3 months of 10-h per-day TRE did not lead to clinically relevant effects on bodyweight in middle-aged to older individuals at high risk of type 2 diabetes. FUNDING: Novo Nordisk Foundation, Aalborg University, Helsefonden, and Innovation Fund Denmark.


Body Weight , Diabetes Mellitus, Type 2 , Humans , Diabetes Mellitus, Type 2/epidemiology , Middle Aged , Female , Male , Denmark/epidemiology , Aged , Follow-Up Studies , Adult , Overweight , Obesity/epidemiology
2.
J Clin Transl Sci ; 7(1): e231, 2023.
Article En | MEDLINE | ID: mdl-38028337

Introduction: Increasing interest in real-world evidence has fueled the development of study designs incorporating real-world data (RWD). Using the Causal Roadmap, we specify three designs to evaluate the difference in risk of major adverse cardiovascular events (MACE) with oral semaglutide versus standard-of-care: (1) the actual sequence of non-inferiority and superiority randomized controlled trials (RCTs), (2) a single RCT, and (3) a hybrid randomized-external data study. Methods: The hybrid design considers integration of the PIONEER 6 RCT with RWD controls using the experiment-selector cross-validated targeted maximum likelihood estimator. We evaluate 95% confidence interval coverage, power, and average patient time during which participants would be precluded from receiving a glucagon-like peptide-1 receptor agonist (GLP1-RA) for each design using simulations. Finally, we estimate the effect of oral semaglutide on MACE for the hybrid PIONEER 6-RWD analysis. Results: In simulations, Designs 1 and 2 performed similarly. The tradeoff between decreased coverage and patient time without the possibility of a GLP1-RA for Designs 1 and 3 depended on the simulated bias. In real data analysis using Design 3, external controls were integrated in 84% of cross-validation folds, resulting in an estimated risk difference of -1.53%-points (95% CI -2.75%-points to -0.30%-points). Conclusions: The Causal Roadmap helps investigators to minimize potential bias in studies using RWD and to quantify tradeoffs between study designs. The simulation results help to interpret the level of evidence provided by the real data analysis in support of the superiority of oral semaglutide versus standard-of-care for cardiovascular risk reduction.

3.
Am J Physiol Endocrinol Metab ; 325(3): E244-E251, 2023 09 01.
Article En | MEDLINE | ID: mdl-37436962

To examine whether fasting plasma liver-expressed antimicrobial peptide 2 (FP-LEAP2) is associated with markers of cardiometabolic disease susceptibility in a cohort with prediabetes and overweight/obesity and whether antidiabetic interventions affect FP-LEAP2 levels. The analysis included 115 individuals with prediabetes [hemoglobin A1c (HbA1c) 39-47 mmol/mol, 5.7%-6.4%] and overweight/obesity [body mass index (BMI) ≥ 25 kg/m2] from a randomized controlled trial. Changes in FP-LEAP2 levels were assessed in relation to treatment with dapagliflozin (10 mg once daily), metformin (1,700 mg daily), or interval-based exercise (5 days/wk, 30 min/session) compared with control (habitual lifestyle) after 6 and 13 wk of treatment. FP-LEAP2 levels were positively associated with [standardized beta coefficient (95% CI)]: BMI 0.22 (0.03:0.41), P = 0.027; body weight 0.27 (0.06:0.48), P = 0.013; fat mass 0.2 (0.00:0.4), P = 0.048; lean mass 0.47 (0.13:0.8), P = 0.008; HbA1c 0.35 (0.17:0.53), P < 0.001; fasting plasma glucose (FPG) 0.32 (0.12:0.51), P = 0.001; fasting serum insulin 0.28 (0.09:0.47), P = 0.005; total cholesterol 0.19 (0.01:0.38), P = 0.043; triglycerides 0.31 (0.13:0.5), P < 0.001; and transaminases and fatty liver index (standardized beta coefficients 0.23-0.32), all P < 0.020. FP-LEAP2 levels were inversely associated with insulin sensitivity [-0.22 (-0.41: -0.03), P = 0.022] and kidney function [estimated glomerular filtration rate (eGFR) -0.34 (-0.56: -0.12), P = 0.003]. FP-LEAP2 levels were not associated with fat distribution or body fat percentage, fasting glucagon, postload glucose, ß-cell function, or low-density lipoprotein. The interventions were not associated with changes in FP-LEAP2. FP-LEAP2 is associated with body mass, impaired insulin sensitivity, liver-specific enzymes, and kidney function. The findings highlight the importance of studying LEAP2 in obesity, type 2 diabetes, and nonalcoholic fatty liver disease. FP-LEAP2 was not affected by metformin, dapaglifloxin, or exercise in this population.NEW & NOTEWORTHY LEAP2, primarily secreted by the liver, increases with greater body mass, insulin resistance, and liver-specific enzymes in individuals with prediabetes and overweight or obesity. Fasting glucose, body mass, and alanine aminotransferase independently predict LEAP2 levels. LEAP2 is inversely linked to impaired kidney function. Elevated LEAP2 levels might indicate an increased metabolic risk, warranting further investigation into its potential involvement in glucose and body weight control.


Cardiovascular Diseases , Diabetes Mellitus, Type 2 , Insulin Resistance , Metformin , Prediabetic State , Humans , Prediabetic State/complications , Hypoglycemic Agents/therapeutic use , Diabetes Mellitus, Type 2/complications , Glycated Hemoglobin , Overweight , Blood Glucose/metabolism , Obesity/complications , Metformin/therapeutic use , Body Weight , Cardiovascular Diseases/epidemiology
4.
Cardiovasc Diabetol ; 21(1): 255, 2022 11 23.
Article En | MEDLINE | ID: mdl-36419118

BACKGROUND: Individuals diagnosed with and treated for type 1 diabetes (T1D) have increased risk of micro- and macrovascular disease and excess mortality. Improving cardiovascular (CV) risk factors in individuals with T1D is known to reduce diabetes- related CV complications. AIM: To examine time trends in CV risk factor levels and CV-protective treatment patterns. Additionally, examine incidence rates of diabetes-related CV complications in relation to exposure CV-protective treatment. METHODS: We analysed records from 41,630 individuals with T1D, registered anytime between 1996 and 2017 in a nationwide diabetes register. We obtained CV risk factor measurements (2010-2017), CV-protective drug profiles (1996-2017) and CV complication history (1977-2017) from additional nationwide health registers. RESULTS: From 2010 to 2017 there were decreasing levels of HbA1c, LDL-C, and blood pressure. Decreasing proportion of smokers, individuals with glycaemic dysregulation (HbA1c ≥ 58 mmol/mol), dyslipidaemia (LDL-C > 2.6 mmol/l), and hypertension (≥ 140/85 mmHg). Yet, one fifth of the T1D population by January 1st, 2017 was severely dysregulated (HbA1c > 75 mmol/mol). A slight increase in levels of BMI and urinary albumin creatinine ratio and a slight decrease in estimated glomerular filtration rate (eGFR) levels was observed. By January 1st, 2017, one fourth of the T1D population had an eGFR < 60 ml/min/1.73 m2. The proportion of the T1D population redeeming lipid-lowering drugs (LLDs) increased from 5% in 2000 to 30% in 2010 followed by a plateau and then a decline. The proportion of the T1D population redeeming antihypertensive drugs (AHDs) increased from 28% in 1996 to 42% in 2010 followed by a tendency to decline. Use of LLDs was associated with lower incidence of micro- and macrovascular complications, while use of AHDs had higher incidence of CVD and CKD, when compared to non-use and discontinued use, respectively. CONCLUSION: Improvements were seen in CV risk factor control among individuals with T1D in Denmark between 2010 and 2017. However, there is clearly a gap between current clinical guidelines and clinical practice for CV risk management in T1D. Action is needed to push further improvements in CV risk control to reduce CVD and the related excess mortality.


Cardiovascular Diseases , Diabetes Mellitus, Type 1 , Humans , Diabetes Mellitus, Type 1/diagnosis , Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 1/epidemiology , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/prevention & control , Cholesterol, LDL , Risk Factors , Heart Disease Risk Factors , Antihypertensive Agents/therapeutic use , Risk Management , Hypolipidemic Agents
5.
Obes Rev ; 23(9): e13462, 2022 09.
Article En | MEDLINE | ID: mdl-35672940

In parallel with an increased focus on climate changes and carbon footprint, the interest in plant-based diets and its potential health effects have increased over the past decade. The objective of this systematic review and meta-analysis was to examine the effect of vegan diets (≥12 weeks) on cardiometabolic risk factors in people with overweight or type 2 diabetes. We identified 11 trials (796 participants). In comparison with control diets, vegan diets reduced body weight (-4.1 kg, 95% confidence interval (CI) -5.9 to -2.4, p < 0.001), body mass index (BMI) (-1.38 kg/m2 , 95% CI -1.96 to -0.80, p < 0.001), glycated hemoglobin (HbA1c ) (-0.18% points, 95% CI -0.29 to -0.07, p = 0.002), total cholesterol (-0.30 mmol/L, 95% CI -0.52 to -0.08, p = 0.007), and low-density lipoprotein cholesterol (-0.24 mmol/L, 95% CI -0.40 to -0.07, p = 0.005). We identified no effect on blood pressure, high-density lipoprotein cholesterol, and triglycerides. We found that adhering to vegan diets for at least 12 weeks may be effective in individuals with overweight or type 2 diabetes to induce a meaningful decrease in body weight and improve glycemia. Some of this effect may be contributed to differences in the macronutrient composition and energy intake in the vegan versus control diets. Therefore, more research is needed regarding vegan diets and cardiometabolic health.


Cardiovascular Diseases , Diabetes Mellitus, Type 2 , Body Weight , Cardiovascular Diseases/prevention & control , Cholesterol, HDL , Diabetes Mellitus, Type 2/prevention & control , Diet, Vegan , Humans , Overweight , Randomized Controlled Trials as Topic
6.
Nutrients ; 14(11)2022 May 30.
Article En | MEDLINE | ID: mdl-35684097

Time-restricted eating (TRE) has been shown to improve body weight and glucose metabolism in people at high risk of type 2 diabetes. However, the safety of TRE in the treatment of type 2 diabetes is unclear. We investigated the safety of TRE interventions in people with type 2 diabetes by identifying published and ongoing studies. Moreover, we identified the commonly used antidiabetic drugs and discussed the safety of TRE in people with type 2 diabetes considering the use of these drugs. In addition, we addressed the research needed before TRE can be recommended in the treatment of type 2 diabetes. A literature search was conducted to identify published (MEDLINE PubMed) and ongoing studies (ClinicalTrials.gov) on TRE in people with type 2 diabetes. To assess the usage of antidiabetic drugs and to discuss pharmacodynamics and pharmacokinetics in a TRE context, the most used antidiabetic drugs were identified and analysed. Statistics regarding sale of pharmaceuticals were obtained from MEDSTAT.DK which are based on data from the national Register of Medicinal Product Statistics, and from published studies on medication use in different countries. Four published studies investigating TRE in people with type 2 diabetes were identified as well as 14 ongoing studies. The completed studies suggested that TRE is safe among people with type 2 diabetes. Common antidiabetic drugs between 2010 and 2019 were metformin, insulin, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists, sulfonylureas, and sodium-glucose cotransporter-2 inhibitors. Existing studies suggest that TRE is not associated with major safety issues in people with type 2 diabetes as long as medication is monitored and adjusted. However, because of low generalisability of the few studies available, more studies are needed to make concrete recommendations regarding efficacy and safety of TRE in people with type 2 diabetes.


Diabetes Mellitus, Type 2 , Dipeptidyl-Peptidase IV Inhibitors , Sodium-Glucose Transporter 2 Inhibitors , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/drug therapy , Humans , Hypoglycemic Agents/adverse effects , Insulin/therapeutic use
7.
J Nutr ; 152(6): 1574-1581, 2022 06 09.
Article En | MEDLINE | ID: mdl-35325189

BACKGROUND: Eating behaviors are determined by a complex interplay between behavioral and physiologic signaling occurring before, during, and after eating. OBJECTIVES: The aim was to explore how selected behavioral and physiologic variables separately and grouped together predicted intake of 8 different foods. METHODS: One hundred adults with normal weight performed a food preference task combined with biometric measurements (the Steno Biometric Food Preference Task) in the fasting state. The task measured food reward as well as biometric (eye tracking, electrodermal activity, and facial expressions) responses to images of foods varying in fat content and taste. Energy intake from an ad libitum buffet of the same 8 foods as assessed in the preference task was subsequently assessed. A mixed-effects random forest approach was applied to explore how individual and combined measures of food reward and biometric responses predicted energy intake of the 8 single foods. The performance of the different prediction models was compared with the predictions from a linear model including only an intercept (naïve model) using bootstrap cross-validation. RESULTS: Participants had a median [IQR] intake of 369 kJ [126-472 kJ] per food. Combined or separate measures of food reward or biometric responses did not predict energy intake better than the naïve model. CONCLUSIONS: We did not find that the reward or biometric responses to food cues assessed in a clinical setting were useful in predicting energy intake of single foods. However, this study provides a framework in the field of behavioral nutrition for applying machine learning with a focus on individual predictions. This is necessary on the road toward personalized nutrition and provides great potential for handling complex data with multiple variables.This trial was registered at clinicaltrials.gov as NCT03986619.


Cues , Reward , Adult , Biometry , Eating/physiology , Energy Intake , Feeding Behavior , Food , Food Preferences/physiology , Humans , Machine Learning
8.
J Nutr ; 152(5): 1358-1369, 2022 05 05.
Article En | MEDLINE | ID: mdl-35020932

BACKGROUND: The wireless motility capsule (WMC) technique is a noninvasive and radiation-free method for measuring regional and whole gut transit in response to ingestion of a granola bar (SmartBar) or an eggbeater meal. The WMC has the potential to measure gastrointestinal transit in metabolic research as part of a standardized mixed meal tolerance test. OBJECTIVES: To evaluate gastrointestinal transit with the WMC and postprandial plasma/serum concentrations of metabolites and gastrointestinal hormones as well as subjective appetite following ingestion of a SmartBar compared with a standardized mixed meal. METHODS: Fourteen healthy participants [3 men, median (IQR) age 53.8 (45.8; 64.50) y, body weight 63.9 (59.9; 69.7) kg, BMI 23.1 (21.8; 23.9) kg/m2] completed a 2-d crossover study. Following ingestion of either a SmartBar (260 kcal, 7 energy percent (E%) fat, 74E% carbohydrate, and 19E% protein) or a standardized mixed meal (498 kcal, 34E% fat, 49E% carbohydrate, and 17E% protein), participants swallowed the WMC. Blood samples were drawn in the fasted state and postprandially for analyses of gastrointestinal hormones and metabolites. The primary outcome was difference in gastric emptying time between the 2 test days. Wilcoxon signed rank tests were used to test differences between test days. RESULTS: Median (IQR) gastric emptying time was 98.0 (70.0; 113.0) min longer (P = 0.001) and incremental area under the curve of triglyceride, glucose-dependent insulinotropic polypeptide, and peptide YY were 40 mmol/L × min, 45.7%, and 63.7% greater after the standardized mixed meal compared with the SmartBar (all P < 0.001). CONCLUSIONS: The WMC can be used in combination with a standardized mixed meal for evaluation of gastrointestinal transit in healthy men and women. Gastric emptying time was prolonged in response to the standardized mixed meal whereas transit times of the small bowel, colon, and whole gut did not differ between the test meals.


Gastrointestinal Hormones , Gastrointestinal Transit , Carbohydrates , Cross-Over Studies , Female , Gastric Emptying/physiology , Gastrointestinal Transit/physiology , Humans , Male , Meals , Middle Aged
9.
Front Endocrinol (Lausanne) ; 12: 753810, 2021.
Article En | MEDLINE | ID: mdl-34675886

Aims: The oral glucose tolerance test (OGTT) is together with haemoglobin A1c (HbA1c) gold standard for diagnosing prediabetes and diabetes. The objective of this study was to assess the concordance between glucose values obtained from venous plasma versus interstitial fluid after oral glucose administration in 120 individuals with prediabetes and overweight/obesity. Methods: 120 adults with prediabetes defined by HbA1c 39-47 mmol/mol and overweight or obesity who participated in the randomised controlled PRE-D trial were included in the study. Venous plasma glucose concentrations were measured at 0, 30, 60 and 120 minutes during a 75 g oral glucose tolerance test (OGTT) performed on three different occasions within a 26 weeks period. During the OGTT, the participants wore a CGM device (IPro2, Medtronic), which assessed glucose concentrations every five minutes. Results: A total of 306 OGTTs with simultaneous CGM measurements were obtained. Except in fasting, the CGM glucose values were below the OGTT values throughout the OGTT period with mean (SD) differences of 0.2 (0.7) mmol/L at time 0 min, -1.1 (1.3) at 30 min, -1.4 (1.8) at 60 min, and -0.5 (1.1) at 120 min). For measurements at 0 and 120 min, there was a proportional bias with an increasing mean difference between CGM and OGTT values with increasing mean of the two measurements. Conclusions: Due to poor agreement between the OGTT and CGM with wide 95% limits of agreement and proportional bias at 0 and 120 min, the potential for assessing glucose tolerance in prediabetes using CGM is questionable.


Blood Glucose/analysis , Glucose/analysis , Glucose/pharmacology , Administration, Oral , Aged , Extracellular Fluid/chemistry , Female , Glucose Tolerance Test , Glycated Hemoglobin/analysis , Humans , Male , Middle Aged , Obesity/blood , Overweight/blood , Prediabetic State/blood , Prediabetic State/diagnosis
10.
Nutrients ; 13(9)2021 Sep 14.
Article En | MEDLINE | ID: mdl-34579074

Gut-derived hormones have been suggested to play a role in bone homeostasis following food intake, although the associations are highly complex and not fully understood. In a randomized, two-day cross-over study on 14 healthy individuals, we performed postprandial time-course studies to examine the associations of the bone remodeling markers carboxyl-terminal collagen type I crosslinks (CTX) and procollagen type 1 N-terminal propeptide (P1NP) with the gut hormones glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide 1 (GLP-1), and peptide YY (PYY) using two different meal types-a standardized mixed meal (498 kcal) or a granola bar (260 kcal). Plasma concentrations of total GIP, total GLP-1, total PYY, CTX, and P1NP were measured up to 240 min after meal intake, and the incremental area under the curve (iAUC) for each marker was calculated. The iAUC of CTX and P1NP were used to assess associations with the iAUC of GIP, GLP-1, and PYY in linear mixed effect models adjusted for meal type. CTX was positively associated with GIP and GLP-1, and it was inversely associated with PYY (all p < 0.001). No associations of P1NP with GIP or GLP-1 and PYY were found. In conclusion, the postprandial responses of the gut hormones GIP, GLP-1, and PYY are associated with the bone resorption marker CTX, supporting a link between gut hormones and bone homeostasis following food intake.


Bone Remodeling/physiology , Bone Resorption/blood , Bone and Bones/physiology , Eating/physiology , Gastrointestinal Hormones/blood , Postprandial Period , Area Under Curve , Biomarkers/blood , Collagen Type I/blood , Cross-Over Studies , Female , Gastric Inhibitory Polypeptide/blood , Glucagon-Like Peptide 1/blood , Healthy Volunteers , Homeostasis , Humans , Male , Meals , Middle Aged , Peptide Fragments/blood , Peptide YY/blood , Peptides/blood , Procollagen/blood , Receptors, Gastrointestinal Hormone/blood
11.
Article En | MEDLINE | ID: mdl-34059524

INTRODUCTION: Blood oxygen saturation is low compared with healthy controls (CONs) in the supine body position in individuals with type 1 diabetes (T1D) and has been associated with complications. Since most of daily life occurs in the upright position, it is of interest if this also applies in the standing body position. In addition, tissue oxygenation in other anatomical sites could show different patterns in T1D. Therefore, we investigated blood, arm and forehead oxygen levels in the supine and standing body positions in individuals with T1D (n=129) and CONs (n=55). RESEARCH DESIGN AND METHODS: Blood oxygen saturation was measured with pulse oximetry. Arm and forehead mixed tissue oxygen levels were measured with near-infrared spectroscopy sensors applied on the skin. RESULTS: Data are presented as least squares means±SEM and differences (95% CIs). Overall blood oxygen saturation was lower in T1D (CON: 97.6%±0.2%; T1D: 97.0%±0.1%; difference: -0.5% (95% CI -0.9% to -0.0%); p=0.034). In all participants, blood oxygen saturation increased after standing up (supine: 97.1%±0.1%; standing: 97.6%±0.2%; difference: +0.6% (95% CI 0.4% to 0.8%); p<0.001). However, the increase was smaller in T1D compared with CON (CON supine: 97.3%±0.2%; CON standing: 98.0%±0.2%; T1D supine: 96.9%±0.2%; T1D standing: 97.2%±0.1%; difference between groups in the change: -0.4% (95% CI -0.6% to -0.2%); p<0.001). Arm oxygen saturation decreased in both groups after standing and more in those with T1D. Forehead oxygen saturation decreased in both groups after standing and there were no differences between the changes when comparing the groups. CONCLUSION: Compared with CON, individuals with T1D exhibit possible detrimental patterns of tissue oxygen adaptation to standing, with preserved adaptation of forehead oxygenation. Further studies are needed to explore the consequences of these differences.


Diabetes Mellitus, Type 1 , Humans , Oximetry , Oxygen , Spectroscopy, Near-Infrared
12.
Nutrients ; 12(11)2020 Nov 13.
Article En | MEDLINE | ID: mdl-33202807

Knowledge on how energy intake and macronutrients are distributed during the day and the role of daily eating patterns in body composition among adults with overweight/obesity and prediabetes is lacking. Therefore, we evaluated the diurnal dietary intake and studied the associations of daily eating patterns with body fat percentage. A total of 119 adults with prediabetes were included (mean (SD) HbA1c 41 (2.3) mmol/mol, BMI 31.5 (5.0) kg/m2, age 57.8 (9.3) years, 44% men). Information on dietary intake was obtained from self-reported food records for three consecutive days. All foods and beverages (except water) were registered with information on time of ingestion. Body fat was measured by dual-energy X-ray absorptiometry. A total of 60.5% of the participants reported a daily eating window of 12 or more hours/day, and almost half of the daily total energy intake was reported in the evening. In analyses adjusted for age, gender, and total daily energy intake, having the first daily energy intake one hour later was associated with slightly higher body fat percentage (0.64% per hour, 95% CI: 0.28; 1.01; p < 0.001), whereas higher meal frequency was associated with slightly lower body fat percentage (0.49% per extra daily meal, 95% CI: -0.81; -0.18; p = 0.002). Prospective studies are warranted to address the clinical implications of daily eating patterns on body fat and cardiometabolic health.


Adipose Tissue , Energy Intake , Obesity , Overweight , Prediabetic State , Absorptiometry, Photon , Adult , Beverages , Body Composition , Cross-Sectional Studies , Eating , Feeding Behavior , Female , Humans , Male , Nutrients , Prospective Studies
13.
Int J Epidemiol ; 47(2): 634-641, 2018 04 01.
Article En | MEDLINE | ID: mdl-29425361

Background: In recent years, human papillomavirus (HPV) vaccination of boys has been added to childhood vaccination programmes in several countries but, so far, no systematic population-based assessment with long-term follow-up has been undertaken of the relative incidence of adverse outcomes following HPV vaccination in this group. We investigated if quadrivalent HPV (qHPV) vaccination of 10-17-year-old boys is associated with any unusual risk of autoimmune diseases, neurological diseases or venous thromboembolism. Methods: We conducted a national cohort study of 568 410 boys born in Denmark 1988-2006 and followed for 4 million person-years during 2006-16, using nationwide registers to obtain individual-level information about received doses of the qHPV vaccine and hospital records for 39 autoimmune diseases, 12 neurological diseases and venous thromboembolism. For each outcome, we estimated incidence rate ratios (RRs) with 95% confidence intervals (CIs) according to qHPV vaccination status. Results: Altogether 7384 boys received at least one dose of the qHPV vaccine at age 10-17 years. Overall, RRs were close to unity for the combined groups of autoimmune diseases (RR = 0.96; 95% CI: 0.71-1.28, n = 46 cases in qHPV-vaccinated boys) and neurological diseases (RR = 0.67; 0.41-1.10, n = 16), as well as for venous thromboembolism (RR = 0.88; 0.33-2.35, n = 4). After taking multiple testing into account, none of the 52 individual outcomes studied appeared to occur in excess among qHPV-vaccinated boys. Conclusions: Although additional large-scale epidemiological studies are warranted, our findings provide population-based reassurance that qHPV vaccination of 10-17-year-old boys is unlikely to be associated with an elevated risk of autoimmune diseases, neurological diseases or venous thromboembolism.


Autoimmune Diseases/epidemiology , Nervous System Diseases/epidemiology , Papillomavirus Vaccines/adverse effects , Venous Thromboembolism/epidemiology , Adolescent , Child , Cohort Studies , Denmark/epidemiology , Humans , Male , Papillomavirus Infections/prevention & control , Poisson Distribution , Risk Assessment , Vaccination/adverse effects
14.
Contact Dermatitis ; 71(2): 75-81, 2014 Aug.
Article En | MEDLINE | ID: mdl-24697272

BACKGROUND: Both atopic dermatitis and contact sensitization are common conditions; however, a definite understanding of the relationship between contact sensitization and atopic dermatitis has not been reached. OBJECTIVES: In this descriptive study, we investigated the differences between positive patch test reactions in patients with and without atopic dermatitis in a patch test cohort, and explored the influence of disease severity. PATIENTS/MATERIALS/METHODS: Patch test results, information on atopic dermatitis and demographic variables were taken from a database, including all patients patch tested at Bispebjerg and Roskilde Hospitals from January 2009 to January 2013. Severe atopic dermatitis was defined as systemic therapy or hospitalization resulting from atopic dermatitis. All other patients with atopic dermatitis were defined as having mild/moderate disease. RESULTS: The study included 2221 patients: 293 patients with atopic dermatitis and 1928 without. Forty-one per cent of patients with and 46.2% of patients without atopic dermatitis had at least one positive patch test reaction (p = 0.092). More patients with severe atopic dermatitis than patients with non-severe atopic dermatitis had multiple positive patch test reactions (19.4% versus 10.0%, p = 0.046). CONCLUSIONS: Overall, we found similar frequencies of positive patch test reactions in patients with and without atopic dermatitis. However, a higher frequency of multiple sensitizations was found in patients with severe atopic dermatitis.


Dermatitis, Allergic Contact/diagnosis , Dermatitis, Atopic/diagnosis , Adult , Allergens , Databases as Topic , Denmark , Dermatitis, Allergic Contact/etiology , Dermatitis, Atopic/chemically induced , Dermatitis, Occupational/diagnosis , Dermatitis, Occupational/etiology , Facial Dermatoses/chemically induced , Facial Dermatoses/diagnosis , Female , Hand Dermatoses/chemically induced , Hand Dermatoses/diagnosis , Hospitals , Humans , Leg Dermatoses/chemically induced , Leg Dermatoses/diagnosis , Male , Patch Tests/methods , Severity of Illness Index
15.
Eur Arch Otorhinolaryngol ; 270(12): 3163-7, 2013 Nov.
Article En | MEDLINE | ID: mdl-23568043

Peritonsillar abscess (PTA) is a frequent complication to acute tonsillitis, in particular in adolescents and young adults. Smoking is most commonly initiated during adolescence and young adulthood. The study examines whether smoking increases the risk of PTA and whether smoking is associated with the bacterial findings in PTA. All patients with PTA admitted to the Ear-Nose-Throat Department at Aarhus University Hospital from January 2001 through December 2006 were included in the study. Age- and gender-stratified data on smoking habits in the Danish population and demographic data for Aarhus County for the same 6 years were obtained. Smoking status was available for 679 (80 %) of 847 patients with PTA. 247 (36 %) patients admitted to daily tobacco smoking. Age-stratified odds ratios of smokers compared to non-smokers, for developing PTA, were in the range of 1.9-4.7. Fusobacterium necrophorum and beta-hemolytic streptococci were equally distributed between smokers and non-smokers. Twenty nine percent of the higher incidence of PTA among males compared to females could be explained by a higher prevalence of smoking in males. After correcting for differences in smoking prevalence by gender, the risk of PTA was calculated to be 9.5 % higher among males than females. Smoking was associated with significantly increased risk of PTA in both males and females of all ages. No differences in the microbiological flora of smokers and non-smokers with PTA were found.


Peritonsillar Abscess/etiology , Smoking/adverse effects , Adolescent , Adult , Denmark/epidemiology , Female , Humans , Male , Middle Aged , Peritonsillar Abscess/epidemiology , Prevalence , Smoking/epidemiology
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