Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
Study NCT ID:
NCT06240208
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2024-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physical Inactivity and Appetite Regulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2024-01-17', 'studyFirstSubmitQcDate': '2024-01-26', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in secretion of gut hormones (GLP-1, GIP, PYY, ghrelin, CCK)', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)'}, {'measure': 'Change in gastric emptying rate', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Measured by surrogate marker paracetamol'}, {'measure': 'Change in body composition (body weight, body mass index, lean mass, fat mass)', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Based on DXA scans'}, {'measure': 'Change in physical fitness (maximal aerobic capacity, one repetition max)', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)'}, {'measure': 'Change in plasma glucose during ad libitum meal', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'AUC (mol/hour)'}, {'measure': 'Change in plasma insulin during ad libitum meal', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'AUC (mol/h)'}, {'measure': 'Change in plasma c-peptide during ad libitum meal', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'AUC (mol/hour)'}, {'measure': 'Change in glucagon supression during ad libitum meal', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'The % glucagon supression at time 0-30min, 0-60min and 0-120min'}, {'measure': 'Change in plasma insulin/glucagon ratio during ad libitum meal', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Insulin/glucagon at time=30, 60 and 120'}, {'measure': 'Change in plasma glucose during mixed meal tolerance test', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'AUC (mol/hour)'}, {'measure': 'Change in plasma insulin during mixed meal tolerance test', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'AUC (mol/hour)'}, {'measure': 'Change in insulin/c-peptide ratio during mixed meal tolerance test', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Insulin/glucagon at time 30min, 60min, 120min and 180'}, {'measure': 'Change in plasma c-peptide during mixed meal tolerance test', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'AUC (mol/hour)'}, {'measure': 'Change in glucagon supression during mixed meal tolerance test', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'The % glucagon supression at time 0-30min, 0-60min, 0-120min and 0-180'}, {'measure': 'Change in plasma insulin/glucagon ratio during mixed meal tolerance test', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Insulin/glucagon at time 30min, 60min, 120min and 180'}, {'measure': 'Change in plasma concentration of cytokines (IL-1Ra, IL-6, IL-10, CRP, TNF-α, GDF-15)', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)'}, {'measure': 'Change in plasma concentration of adipokines (leptin and adiponectin)', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)'}, {'measure': 'Change in glycaemic variability', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'CV% derived from free-living continuous glucose monitoring'}, {'measure': 'Change in glycaemic variability', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'SD derived from free-living continuous glucose monitoring'}, {'measure': 'Change in glycaemic variability', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Mean glucose derived from free-living continuous glucose monitoring'}, {'measure': 'Change in glycaemic variability', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Time in range derived from free-living continuous glucose monitoring'}, {'measure': 'Change in physical and mental well-being', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Based on scores from WHO5, HAM-DS-S, and GAD-10 questionnaires'}, {'measure': 'Change in physical and mental well-being', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Based on scores from WHO5 questionnaires'}, {'measure': 'Change in symptoms of depression', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Based on scores from HAM-D6-S questionnaires'}, {'measure': 'Change in symptoms of anxiety', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Based on scores from GAD-10 questionnaires'}, {'measure': 'Change in sleep Quality', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Based on scores from Pittsburgh Sleep Quality Index'}, {'measure': 'Change in plasma peptides', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Evaluated by peptidomics'}, {'measure': 'Change in plasma metabolites', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Evaluated by metabolomics'}], 'primaryOutcomes': [{'measure': 'The change in food intake at an ad libitum meal during GLP-1 infusion', 'timeFrame': 'From baseline (week 0) to follow-up (week 2).', 'description': 'Food intake will be evaluated as ingested food in grams'}], 'secondaryOutcomes': [{'measure': 'The change in preference for unhealthy food ( combined score for high fat food, savory food, and sweet food).', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Evaluated by visual food stimuli combined with eye tracking'}, {'measure': 'The change in subjective experience of severity and type of food cravings', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Evaluated by the Control of Eating Questionnaire.'}, {'measure': 'The change in subjective feeling of satiety', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Evaluated by a visual analogue scale'}, {'measure': 'The change in subjective felling of hunger', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Evaluated by a visual analogue scale'}, {'measure': 'The change in satiety composite appetite score', 'timeFrame': 'From baseline (week 0) to follow-up (week 2)', 'description': 'Calculated from visual analog scales'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight']}, 'descriptionModule': {'briefSummary': 'The goal of this parallel-group, two-arm, assessor-blinded, randomised clinical trial is to investigate the effects of reducing physical activity on food intake and satiety in physically active and healthy males, 40-55 years of age.\n\nThe main questions it aims to answer are:\n\n* Does physical inactivity affect GLP-1 stimulated food intake?\n* Does physical inactivity affect food preferences, satiety and other mechanisms supporting appetite regulation?\n\nParticipants will be randomised (1:1) to two weeks of either no intervention (control group) or inactivity. Inactivity will be implemented as cessation of active commuting and all other structured exercise. Furthermore, steps will be reduced to a maximum of 1500 steps/day.\n\nResearchers will compare the inactivity group to the control group to see if physical inactivity impairs appetite regulation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male\n2. Age ≥ 40 years and ≤ 55 years\n3. Body mass index (BMI) \\> 20 and \\< 25 kg/m2\n4. Physical activity level should as a minimum include: Active commuting by biking a minimum of 10 km, four days per week or an equivalent amount of other physical activity four days per week.\n5. Healthy (based on self-reporting, pre-study medical examination and biochemical screening)\n6. Can adhere to two weeks of inactivity (refrain from running, cycling and all other exercise while reducing steps to max. 1500 pr. day)\n7. Caucasian\n8. No change in body weight \\> 5 kg within the last 6 months\n9. Eats breakfast and lunch daily\n10. Does not follow specific dietary restrictions\n11. No disliking of spaghetti bolognese\n12. No diagnosis of psychiatric disorder or treatment with anti-depressant or anti-psychotic medication\n13. No history of suicidal behavior or ideations.\n14. No previous surgical treatment for obesity\n15. No cardiovascular disease\n16. No rheumatologic disease\n17. No metabolic/endocrine disease\n18. No liver disease (ASAT or ALAT \\>2x upper normal range)\n19. No other chronic disease\n20. No elite sports\n21. No frequent or chronic use of medications affecting bodyweight, physical performance, or inflammation (NSAIDS, DMARDS, corticosteroids)\n22. No current infection\n23. No history of cancer\n24. No anemia (hematocrit \\<33%)\n25. No smoking\n26. No participation in other research intervention studies\n\nExclusion Criteria:\n\n1. Clinical or biochemical signs of disease\n2. HbA1c \\> 39 mmol/mol\n3. Unable to allocate the needed time to fulfill the intervention\n4. Language barrier, mental incapacity, unwillingness, or inability to understand and be able to complete the interventions'}, 'identificationModule': {'nctId': 'NCT06240208', 'briefTitle': 'Physical Inactivity and Appetite Regulation', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'The Effects of Inactivity on GLP-1 Stimulated Appetite Regulation in Healthy Normal Weight Males: A Randomised, Parallel Group Study', 'orgStudyIdInfo': {'id': 'H-23055497'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inactivity', 'description': 'Inactivity will be implemented as cessation of active commuting and all other structured exercise. Furthermore, steps will be reduced to a maximum of 1500 steps/day.', 'interventionNames': ['Behavioral: Inactivity']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants will be instructed to maintain habitual physical activity and dietary habits.'}], 'interventions': [{'name': 'Inactivity', 'type': 'BEHAVIORAL', 'description': 'Inactivity will be implemented as cessation of active commuting and all other structured exercise. Furthermore, steps will be reduced to a maximum of 1500 steps/day.', 'armGroupLabels': ['Inactivity']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Grit E Legård', 'role': 'CONTACT', 'email': 'grit.elster.legaard@regionh.dk', 'phone': '+45 35457641'}], 'facility': 'Copenhagen University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Inge Holm', 'role': 'CONTACT', 'email': 'inge.holm@regionh.dk', 'phone': '+45 35 45 76 41'}, {'name': 'Bente K Pedersen, Dr Med', 'role': 'CONTACT', 'email': 'Bente.Klarlund.Pedersen@regionh.dk', 'phone': '+45 35 45 76 41'}], 'overallOfficials': [{'name': 'Grit Elster Legård, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Physical Activity Research, Rigshospitalet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'If the data can be fully anonymized the data can be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, {'name': 'TrygFonden, Denmark', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Grit Elster Legård', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}