Protocol for a 1-year randomised, controlled, parallel group, open-label trial on the effects and feasibility of time-restricted eating in individuals with type 2 diabetes- The Restricted Eating Time in the Treatment of Type 2 Diabetes (RESET2) trial.

Aim: Time-restricted eating (TRE) limits the time for food intake to typically 6-10 h/day without other dietary restrictions. The aim of the RESET2 (the REStricted Eating Time in the treatment of type 2 diabetes) trial is to investigate the effects on glycaemic control (HbA) and the feasibility of a 1-year TRE intervention in individuals with overweight/obesity and type 2 diabetes. The aim of the present paper is to describe the protocol for the RESET2 trial.

Comparing the Effectiveness of Different Dietary Educational Approaches for Carbohydrate Counting on Glycemic Control in Adults with Type 1 Diabetes: Findings from the DIET-CARB Study, a Randomized Controlled Trial.

Background/objectives: Carbohydrate counting is recommended to improve glycemic control in type 1 diabetes (T1D), but the most effective educational methods are unclear. Despite its benefits, many individuals struggle with mastering carbohydrate counting, leading to inconsistent use and suboptimal glycemic outcomes. This study aimed to compare the effectiveness of two group-based programs with individual dietary counseling (standard care) for glycemic control.

Effects of basic carbohydrate counting versus standard dietary care for glycaemic control in type 2 diabetes (The BCC Study): a randomised, controlled trial.

Background: Clinical guidelines recommend basic carbohydrate counting (BCC), or similar methods to improve carbohydrate estimation skills and to strive for higher consistency in carbohydrate intake potentially improving glycaemic control. However, evidence for this approach in type 2 diabetes (T2D) is limited.

Objective: To examine the efficacy of a structured education program in BCC as add-on to standard dietary care on glycaemic control in individuals with T2D.

Extracellular matrix turnover proteins as risk markers in people with type 2 diabetes and microalbuminuria.

Background: This post-hoc study investigated whether biomarkers reflecting extracellular matrix (ECM) turnover predicted cardiovascular disease (CVD), mortality, and progression of diabetic kidney disease (DKD) in individuals with type 2 diabetes (T2D) and microalbuminuria.

Methods: Serum levels of specific ECM turnover biomarkers were assessed in 192 participants with T2D and microalbuminuria from an observational study conducted at Steno Diabetes Center Copenhagen from 2007 to 2008. Endpoints included CVD events, mortality, and DKD progression, defined as decline in estimated glomerular filtration rate (eGFR) of >30 %.

Effects of 3 months of 10-h per-day time-restricted eating and 3 months of follow-up on bodyweight and cardiometabolic health in Danish individuals at high risk of type 2 diabetes: the RESET single-centre, parallel, superiority, open-label, randomised controlled trial.

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).

Healthy weight loss maintenance with exercise, GLP-1 receptor agonist, or both combined followed by one year without treatment: a post-treatment analysis of a randomised placebo-controlled trial.

Background: New obesity medications result in large weight losses. However, long-term adherence in a real-world setting is challenging, and termination of obesity medication results in weight regain towards pre-treatment body weight. Therefore, we investigated whether weight loss and improved body composition are sustained better at 1 year after termination of active treatment with glucagon-like peptide-1 (GLP-1) receptor agonist, supervised exercise program, or both combined for 1 year.

The effect of metformin treatment on volumes of free-living physical activity and sedentary behaviour: A post-hoc analysis of the PRE-D trial.

Perceived physical exertion is increased when exercise is performed on metformin treatment, but the clinical relevance of this is unknown. In this post hoc analysis of a randomized, controlled trial, we investigated whether metformin treatment was associated with lower levels of free-living physical activity.   Ninety individuals with overweight/obesity (BMI>25 m/kg) and HbAc-defined prediabetes (39-47 mmol/mol) were randomized to treatment with dapagliflozin (SGLT2-inhibitor; 10 mg once daily, n=30), metformin (850 mg twice daily, n=30) or no treatment (control, n=30) for 13 weeks in a parallel-group, open-label trial.

Albuminuria-lowering effect of adding semaglutide on top of empagliflozin in individuals with type 2 diabetes: A randomized and placebo-controlled study.

Aim: To investigate whether combined treatment with empagliflozin (a sodium-glucose cotransporter-2 inhibitor) and semaglutide (a glucagon-like peptide-1 receptor agonist) can reduce urinary albumin-creatinine ratio (UACR) compared to treatment with empagliflozin alone in individuals with type 2 diabetes (T2D) and albuminuria.

Methods: We conducted a randomized, placebo-controlled, double-blind, parallel study including 60 individuals with T2D and albuminuria. All participants initiated open-label empagliflozin 25 mg once daily, on top of renin-angiotensin system inhibition, in a run-in period of 26 weeks.

Validity and reliability of an app-based medical device to empower individuals in evaluating their physical capacities.

Background: Cardiorespiratory fitness and muscle strength are valid markers of health and strong predictors of mortality and morbidity. The tests used to measure these variables require in-person visits with specialized equipment and trained personnel-leading to organizational constraints both for patients and hospitals, and making them difficult to implement at a large scale. In this context, technologies embedded in smartphones offer new opportunities to develop remote tests.

LEAP2 is associated with cardiometabolic markers but is unchanged by antidiabetic treatment in people with prediabetes.

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.

Predicting the HbA level following glucose-lowering interventions in individuals with HbA-defined prediabetes: a post-hoc analysis from the randomized controlled PRE-D trial.

Purpose: To investigate whether the prediction of post-treatment HbA levels can be improved by adding an additional biomarker of the glucose metabolism in addition to baseline HbA.

Methods: We performed an exploratory analysis based on data from 112 individuals with prediabetes (HbA 39-47 mmol) and overweight/obesity (BMI ≥ 25 kg/m), who completed 13 weeks of glucose-lowering interventions (exercise, dapagliflozin, or metformin) or control (habitual living) in the PRE-D trial. Seven prediction models were tested; one basic model with baseline HbA as the sole glucometabolic marker and six models each containing one additional glucometabolic biomarker in addition to baseline HbA.

The prediabetes conundrum: striking the balance between risk and resources.

The current definition of prediabetes is controversial and subject to continuous debate. Nonetheless, prediabetes is a risk factor for type 2 diabetes, is highly prevalent and is associated with diabetic complications and mortality. Thereby, it has the potential to become a huge strain on healthcare systems in the future, necessitating action from legislators and healthcare providers.

Combination of exercise and GLP-1 receptor agonist treatment reduces severity of metabolic syndrome, abdominal obesity, and inflammation: a randomized controlled trial.

Background: Identifying and reducing cardiometabolic risks driven by obesity remains a healthcare challenge. The metabolic syndrome is associated with abdominal obesity and inflammation and is predictive of long-term risk of developing type 2 diabetes and cardiovascular disease in otherwise healthy individuals living with obesity. Therefore, we investigated the effects of adherent exercise, a glucagon-like peptide 1 receptor agonist (GLP-1 RA), or the combination on severity of metabolic syndrome, abdominal obesity, and inflammation following weight loss.

Maintenance of cardiorespiratory fitness, body composition, and a physically active lifestyle after structured exercise interventions in individuals with overweight and obesity: A mixed-method follow-up study.

Objectives: The aim of this mixed-method study was to explore maintenance of physical activity and health effects one year after completion of exercise interventions in transport and leisure-time domains of everyday life. We hypothesised that routinisation of active commuting would lead to better maintenance of physical activity and health effects compared with leisure-time exercise.

Study Design: Mixed-methods follow-up study.

Effects of acute exercise and exercise training on plasma GDF15 concentrations and associations with appetite and cardiometabolic health in individuals with overweight or obesity - A secondary analysis of a randomized controlled trial.

Growth Differentiation Factor 15 (GDF15) is seemingly involved in appetite control. Acute exercise increases GDF15 concentrations in lean humans, but acute and long-term effects of exercise on GDF15 in individuals with overweight/obesity are unknown. We investigated the effects of acute exercise and exercise training on GDF15 concentrations in individuals with overweight/obesity and associations with appetite and cardiometabolic markers.

The GDF15-GFRAL pathway is dispensable for the effects of metformin on energy balance.

Metformin is a blood-glucose-lowering medication with physiological effects that extend beyond its anti-diabetic indication. Recently, it was reported that metformin lowers body weight via induction of growth differentiation factor 15 (GDF15), which suppresses food intake by binding to the GDNF family receptor α-like (GFRAL) in the hindbrain. Here, we corroborate that metformin increases circulating GDF15 in mice and humans, but we fail to confirm previous reports that the GDF15-GFRAL pathway is necessary for the weight-lowering effects of metformin.

Digital intervention promoting physical activity among obese people (DIPPAO) randomised controlled trial: study protocol.

Introduction: Physical inactivity and excessive sedentary behaviours are major preventable causes in both the development and the treatment of obesity and type 2 diabetes mellitus (T2DM). Nevertheless, current programmes struggle to engage and sustain physical activity (PA) of patients over long periods of time. To overcome these limitations, the Digital Intervention Promoting Physical Activity among Obese people randomised controlled trial (RCT) aims to evaluate the effectiveness of a group-based digital intervention grounded on gamification strategies, enhanced by social features and informed by the tenets of the self-determination theory and the social identity approach.

Discordance Between Glucose Levels Measured in Interstitial Fluid in Venous Plasma After Oral Glucose Administration: A Analysis From the Randomised Controlled PRE-D Trial.

Aims: The oral glucose tolerance test (OGTT) is together with haemoglobin A (HbA) 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 HbA 39-47 mmol/mol and overweight or obesity who participated in the randomised controlled PRE-D trial were included in the study.

Effect of exercise training on skeletal muscle protein expression in relation to insulin sensitivity: Per-protocol analysis of a randomized controlled trial (GO-ACTIWE).

Exercise training improves peripheral insulin sensitivity and leads to molecular adaptations in the skeletal muscle. We investigated changes in the expression of key muscle proteins in the glucose metabolic pathway following active commuting by bike or leisure-time exercise at two different intensities. In addition, potential associations between insulin sensitivity and muscle protein expression were examined.

Healthy Weight Loss Maintenance with Exercise, Liraglutide, or Both Combined.

Background: Weight regain after weight loss is a major problem in the treatment of persons with obesity.

Methods: In a randomized, head-to-head, placebo-controlled trial, we enrolled adults with obesity (body-mass index [the weight in kilograms divided by the square of the height in meters], 32 to 43) who did not have diabetes. After an 8-week low-calorie diet, participants were randomly assigned for 1 year to one of four strategies: a moderate-to-vigorous-intensity exercise program plus placebo (exercise group); treatment with liraglutide (3.

Use of mHealth to Increase Physical Activity Among Breast Cancer Survivors With Fatigue: Qualitative Exploration.

Background: Physical activity has shown beneficial effects in the treatment of breast cancer fatigue; nevertheless, a significant portion of patients remain insufficiently physically active after breast cancer. Currently most patients have a smartphone, and therefore mobile health (mHealth) holds the promise of promoting health behavior uptake for many of them.

Objective: In this study, we explored representations, levers, and barriers to physical activity and mHealth interventions among inactive breast cancer patients with fatigue.

Late-evening food intake is highly prevalent among individuals with type 2 diabetes.

Late-evening food intake is associated with cardiometabolic risk. We assessed the prevalence of late-evening and night-time eating in individuals with type 2 diabetes and its association with BMI and HbA. We hypothesized food intake during late evening and night-time to be prevalent among individuals with type 2 diabetes and to be associated with higher BMI and higher HbA.

No effects of dapagliflozin, metformin or exercise on plasma glucagon concentrations in individuals with prediabetes: A post hoc analysis from the randomized controlled PRE-D trial.

Aim: To assess the effects of dapagliflozin, metformin and exercise treatment on changes in plasma glucagon concentrations in individuals with overweight and HbA1c-defined prediabetes.

Materials And Methods: One-hundred and twenty individuals with overweight (body mass index ≥ 25 kg/m ) and prediabetes (HbA1c of 39-47 mmol/mol) were randomized to a 13-week intervention with dapagliflozin (10 mg once daily), metformin (850 mg twice daily), exercise (30 minutes of interval training 5 days per week) or control (habitual living). A 75-g oral glucose tolerance test (OGTT) (0, 30, 60 and 120 minutes) was administered at baseline, at 13 weeks (end of intervention) and at 26 weeks (end of follow-up).

The effects of dapagliflozin, metformin or exercise on glycaemic variability in overweight or obese individuals with prediabetes (the PRE-D Trial): a multi-arm, randomised, controlled trial.

Aims/hypothesis: We aimed to investigate the short-term efficacy and safety of three glucose-lowering interventions in overweight or obese individuals with prediabetes defined by HbA.

Methods: The PRE-D Trial was a randomised, controlled, parallel, multi-arm, open-label, non-blinded trial performed at Steno Diabetes Center Copenhagen, Gentofte, Denmark. One hundred and twenty participants with BMI ≥25 kg/m, 30-70 years of age, and prediabetes (HbA 39-47 mmol/mol [5.

Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study.

Introduction: The aim of this study is to investigate the effects of time-restricted eating (TRE) on change in body weight and describe changes in behaviour and metabolism in individuals at high risk of type 2 diabetes.

Methods And Analysis: The REStricted Eating Time (RESET) study is a randomised controlled parallel-group open-label trial. 100 women and men with (1) overweight (body mass index (BMI)≥25 kg/m) and prediabetes (glycated haemoglobin 39-47 mmol/mol); or (2) obesity (BMI≥30 kg/m) will be randomised to a control group (habitual living) or TRE (self-selected 10-hours eating window within the period from 06:00 to 20:00 in a 1:1 ratio.