Hedonic and Homeostatic Appetite Control in Obesity and Type 2 Diabetes in the Context of Meal and Exercise Timing

NCT05768958 | Active Not Recruiting

• 1 other identifier: H-22019913
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight and Obesity; Type 2 Diabetes

Keywords

Overweight; Obesity; Timing; Acute exercise; Circadian rythm; Appetite; Type 2 diabetes; Metabolism

Outcome Measures

Primary Outcomes (1)

• Ad libitum energy intake (KJ) after exercise compared with rest

  Food intake (KJ) is measured after meal completion, exercise compared with rest

  Measured after meal consumption at t = 30 minutes

Secondary Outcomes (37)

• Ad libitum energy intake (KJ) after exercise in the morning compared with evening

  Measured after meal consumption at t = 30 minutes

• Ad libitum energy intake (KJ) after rest in the morning compared with evening

  Measured after meal consumption at t = 30 minutes

• Eating pace (KJ/min)

  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)

  Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest

• Triglyceride (mmol/L)

  Fasting (t = -60 minutes) and at t = 0, 15, 30, 45, 60 minutes, morning and evening, exercise and rest

Study Arms (4)

Morning exercise

EXPERIMENTAL

Study visit performed in the morning with 45 min exercise.

Other: Exercise

Morning control

EXPERIMENTAL

Study visit performed in the morning with 45 min rest period.

Other: Control

Evening exercise

EXPERIMENTAL

Study visit performed in the evening with 45 min exercise.

Other: Exercise

Evening control

EXPERIMENTAL

Study visit performed in the evening with 45 min rest period.

Other: Control

Interventions

Exercise OTHER

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.

Evening exercise; Morning exercise

Control OTHER

45 min rest during the same time period as the exercise bout on exercise study visits.

Evening control; Morning control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with overweight or obesity (BMI \>25 kg/m2) with and without T2D
• HbA1c ≥48 mmol/mol for people with T2D

You may not qualify if:

• Not able to eat ad libitum meal
• Not able to perform the exercise bout
• Daily smoking
• For women: Pregnancy / planned pregnancy (within the study period) / lactating
• Self-reported history of an eating disorder in the past 3 years
• Treatment with antidepressants
• Treatment with fast acting insulin, combination insulin products and sulfonylureas
• Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, gastrointestinal, or psychiatric disease; diabetes or other endocrine disease; immunosuppression
• Current treatment with medication which significantly affect appetite or energy balance (e.g., GLP-1 receptor agonists)
• Bariatric surgery
• Unable to understand the informed consent and the study procedures
• Concomitant participation in intervention studies
• Incapable of understanding Danish

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• University of Leeds: collaborator
• Novo Nordisk A/S: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, DK-2730, Denmark

Location

Related Publications (1)

• Jalking L, Launbo NP, Jensen MM, Pedersen HE, Blond MB, Gerstenberg MK, Finlayson G, Beaulieu K, Faerch K, Grunnet LG, Quist JS. Effects of exercise and exercise timing on energy intake and appetite control in Danish individuals with overweight or obesity with and without type 2 diabetes: a protocol for a randomised controlled cross-over trial. BMJ Open. 2025 Feb 6;15(2):e092683. doi: 10.1136/bmjopen-2024-092683.

  PMID: 39915022 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kristine Færch, PhD

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 15, 2023
• Study Start: March 22, 2023
• Primary Completion: August 21, 2024
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

DK (1)