An interventional study of Exercise and Control in Overweight and Obesity and Type 2 Diabetes, sponsored by Steno Diabetes Center Copenhagen. Active, not recruiting at 1 site in Denmark. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by Steno Diabetes Center Copenhagen · Not applicable, Interventional, and Treatment
The overall aim is to investigate effects of acute exercise on ad libitum energy intake and study whether this differs between morning and evening in individuals with overweight/obesity with or without type 2 diabetes (T2D). Furthermore, the aim is to examine the role of hedonic and homeostatic drivers of appetite control in obesity and T2D in the context of meal and exercise timing.
Fifty-eight adults (age 18 - 75 years old) with overweight/obesity (BMI >25 kg/m2) and with/without T2D will participate in this randomized cross-over study. Participants will complete two visits in the morning and two in the evening with a minimum of 3 days washout. The visits will include ratings of subjective appetite and blood samples in the fasted state followed by either a 45 min exercise bout or rest for the same duration. 15 min after the termination of the exercise bout/rest period the participants will be presented with an ad libitum meal for assessment of energy intake (primary outcome). Then the participants will complete the Steno Biometric Food Preference Task (SBFPT); A computerized task measuring food choice, explicit liking, and implicit and explicit wanting with concomitant biometric measurements. Throughout the visits, subjective appetite will be rated using visual analogue scales and blood will be collected for assessment of appetite-related hormones and metabolites.
(Time: -60 minutes (fasting), -45 minutes (start exercise/rest), 0 minutes (finish exercise/rest), 15 minutes (ad libitum meal), 30 minutes (finish al libitum meal), 60 minutes (end of visit)
Descriptive data will be collected at a visit prior to the test days. These data include body weight (kg), Body Mass Index (BMI, kg/m2), fat mass (kg), fat free mass (kg), fat percentage (%), HbA1c (mmol/mol and %), waist circumference (cm), VO2-0peak and ECG. The participants will furthermore fill in questionnaires regarding the following: Socio-Economic Status (SES), Control Over Eating (CoEQ), Munich Chronotype Questionnaire (MCTQ), Physical Activity Questionnaires (IPAQ), Pittsburgh Sleep Quality Index (PSQI). In addition to the outcomes listed below, markers of liver function (Alanine aminotransferase (ALAT), Aspartate Transaminase (ASAT)), HbA1c, sodium, and potassium will be measured in the fasting state on the first morning visit.
The specific objectives are to:
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 58 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
Study visit performed in the morning with 45 min exercise.
Other: Exercise
Study visit performed in the morning with 45 min rest period.
Other: Control
Study visit performed in the evening with 45 min exercise.
Other: Exercise
Study visit performed in the evening with 45 min rest period.
Other: Control
45 min exercise bout performed on bicycle ergometer. The exercise bout will consist of a 10 min warm-up period at 40 % Watt max followed by 4 cycles of 4 min at 85 % Watt max and 3 min at 50 % Watt max. A cool-down period (7 min) will be performed at 40 % Watt max.
45 min rest during the same time period as the exercise bout on exercise study visits.
Ad libitum energy intake (KJ) after exercise compared with rest
Food intake (KJ) is measured after meal completion, exercise compared with rest
Time frame: Measured after meal consumption at t = 30 minutes
Ad libitum energy intake (KJ) after exercise in the morning compared with evening
Assess whether energy intake during an ad libitum meal after exercise differs between morning and evening
Time frame: Measured after meal consumption at t = 30 minutes
Ad libitum energy intake (KJ) after rest in the morning compared with evening
Assess whether energy intake during an ad libitum meal after rest differs between morning and evening
Time frame: Measured after meal consumption at t = 30 minutes
Eating pace (KJ/min)
Energy intake relative to duration of meal consumption
Time frame: Measured from start to finish of meal consumption at t = 15 minutes to end of meal, morning and evening, exercise and rest
Glucose (mmol/L)
Concentrations of glucose
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Triglyceride (mmol/L)
Concentrations of triglyceride
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Total cholesterol (mmol/L)
Concentrations of total cholesterol
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
LDL cholesterol (mmol/L)
Concentrations of LDL cholesterol
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
HDL cholesterol (mmol/L)
Concentrations of HDL cholesterol
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
VLDL cholesterol (mmol/L)
Concentrations of VLDL cholesterol
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Free-Fatty Acids (mmol/L)
Concentrations of Free-Fatty Acids.
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Circulating metabolides (metabolomics) (g/mL)
Concentrations of circulating metabolides measured with metabolomic analysis
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Circulating lipids (lipidomics) (g/mL)
Concentrations of circulating lipids measured with lipidomic analysis
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Circulating proteins (proteomics) (g/mL)
Concentrations of circulating proteins measured with proteomic analysis
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Insulin (pmol/L)
Concentrations of insulin
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Glucagon (pmol/L)
Concentrations of glucagon
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Total ghrelin (pmol/L)
Concentrations of total ghrelin
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Acylated ghrelin (pmol/L)
Concentrations of acylated ghrelin
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Glucagon-Like Peptide-1 (GLP-1) (pmol/L)
Concentrations of Glucagon-Like Peptide-1 (GLP-1)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Glucose-Dependent Insulinotropic polypeptide (GIP) (pmol/L)
Concentrations of Glucose-Dependent Insulinotropic polypeptide (GIP)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
C-peptide (pmol/L)
Concentrations of C-peptide
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Peptide YY (PYY) (pmol/L)
Concentrations of Peptide YY (PYY)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Peptide YY (PYY) 3-36 (pmol/L)
Concentrations of Peptide YY (PYY) 3-36
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Fibroblast Growth Factor 21 (FGF-21) (pmol/L)
Concentrations of Fibroblast Growth Factor 21 (FGF-21)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Leptin (pmol/L)
Concentrations of Leptin
Time frame: Fasting (t = -60 minutes), and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Growth Differentiation Factor 15 (GDF-15) (pmol/L)
Concentrations of Growth Differentiation Factor 15 (GDF-15)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Cholecystokinin (CCK) (pmol/L)
Concentrations of Cholecystokinin (CCK)
Time frame: Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Pancreatic polypeptide (PP) (pmol/L)
Concentrations of Pancreatic polypeptide (PP)
Time frame: Fasting (t = -60 minutes), and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
C-reactive protein (CRP) (pmol(L)
Concentrations of C-reactive protein (CRP)
Time frame: Fasting (t = -60 minutes), and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Food choice
Food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Food choice is determined based on frequency of selection made within each food category. The scores range from 0-48 i.e. 0 = foods within a specific food category have not been selected at all to 48 = foods within a specific food category have been selected 48 times.
Time frame: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Attention
Measured using eye tracking in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire. Includes the following parameters: Gaze: Time spent (ms and %) and revisits (n); and fixations: Time to first fixation (ms), time spent (ms and %), fixation count (n), first fixation duration (ms), average fixation duration (ms). Distance to screen (mm), and gaze direction bias (ratio) which is calculated as the number of trials in which the first fixation was directed to a food image as a proportion to all trials. A bias score ˃0.5 indicates attention towards one food image, a bias score equal to 0.5 indicates no bias, and a bias score \<0.5 indicates attention towards the other food images.
Time frame: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Reaction time (ms)
Reaction time during forced food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire.
Time frame: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Explicit liking
Explicit liking of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Explicit liking is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how pleasant would it be to taste this food right now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).
Time frame: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Implicit wanting
Implicit wanting of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Implicit wanting is assessed based on food choice and response time for selected and non-selected food items as well as mean response time (a frequency-weighted algorithm). In this frequency-weighted algorithm a positive score indicates a more rapid preference for a food type over another food type and a negative score indicates the opposite. A score of zero indicates that food types are equally preferred. The frequency weighted algorithm is used so the implicit wanting score is influenced by both selection (positively contributing to the score) and non-selection (negatively contributing to the score) of food type. Scores for implicit wanting typically range from -100-100 (due to reaction time there is no fixed min-max value)
Time frame: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Explicit wanting
Explicit wanting of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Explicit wanting is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how much do you want some of this food now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).
Time frame: Measured before exercise/rest (t = -60 minutes) and after meal consumption (t= 30 minutes), morning and evening, exercise and rest
Subjective appetite
Rated using visual analogue scales and includes sensations of: Hunger, fullness, satiety, prospective food consumption, wellbeing, nausea, thirst, desire to eat meat, salty, and sweet. The scale range is 0-100 and each end represent the extremes e.g. hunger rating: "I am not hungry at all" to "I have never been this hungry before".
Time frame: Fasting (t = -60, 0 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest
Energy intake (KJ)
Assessed from diet records
Time frame: Registered 24 hours after the test days, morning and evening, exercise and rest
Borg RPE
Subjective rating of the level of exertion during exercise is collected through the Borg Rating of Percieved Exertion (RPE) at baseline and post exercise, and compared between visits.
Time frame: Measured after exercise (t = 0 minutes) , morning and evening
Plan to share: Yes — Data from the trial will not be made publicly available as individual data from participants are protected by EU's GDPR (General Data Protection Regulation) laws and Danish Data Protection laws. Study results can be made available upon reasonable request from the corresponding author.
Supporting information: Study protocol, Icf
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Steno Diabetes Center Copenhagen