Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT06982612
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-21
First Post:
2025-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glycemic Control Following Occupational Work in a Hot Environment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomised, crossover design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-18', 'studyFirstSubmitDate': '2025-05-01', 'studyFirstSubmitQcDate': '2025-05-18', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'N-back task for working memory (cognitive function)', 'timeFrame': '8hours', 'description': 'The task will comprise three progressively harder memory loads (1-Back, 2-Back, 3-Back). Each stimulus type will be used in all memory loads. Participants will have to respond using the space bar when they see a stimulus that is presented one, two, or three steps previously, dependent on the load condition.'}, {'measure': 'Go/no-go task for response inhibition (cognitive function)', 'timeFrame': '8hours', 'description': 'Participants will be instructed to press the space bar when a green image appears onscreen ("go" stimulus) and to inhibit responding when a red image is presented (the "no-go" stimulus). Increased commission error responses (i.e. responding incorrectly on a no-go trial) will indicate reduced response inhibition. Commission errors and correct responses will be measured as indices of performance.'}, {'measure': 'Stroop test', 'timeFrame': '8hours', 'description': 'The Stroop Test is a psychological assessment that measures a person\'s ability to inhibit cognitive interference and control attention. Typically, it involves naming the color of the ink in which a word is printed, even when the word itself names a different color (e.g., the word "red" printed in blue ink). The delay in response time when the word and ink color do not match-known as the Stroop effect-reflects the difficulty of suppressing automatic cognitive processes.'}], 'primaryOutcomes': [{'measure': 'Plasma glucose', 'timeFrame': '8hours', 'description': 'Measured using colorimetric assay from venous blood samples'}], 'secondaryOutcomes': [{'measure': 'Plasma insulin', 'timeFrame': '8hours', 'description': 'Measured using ELISA from venous blood samples'}, {'measure': 'Plasma osmolality', 'timeFrame': '8hours', 'description': 'Measured using freezing point depression from venous blood samples'}, {'measure': 'Plasma volume change', 'timeFrame': '8hours', 'description': 'Determined from haemoglobin and haematocrit measures in blood samples'}, {'measure': 'Urine volume', 'timeFrame': '8hours', 'description': 'Determined from urine samples collected before and after exercise'}, {'measure': 'Body mass', 'timeFrame': '8hours', 'description': 'Determined from weighing participants before and after exercise'}, {'measure': 'Urine specific gravity/osmolality', 'timeFrame': '8hours', 'description': 'Determined from urine samples collected before and after exercise'}, {'measure': 'Rectal temperature', 'timeFrame': '8hours', 'description': 'Measured via rectal probe'}, {'measure': 'Blood pressure', 'timeFrame': '8hours', 'description': 'Measured via and automated sphygmomanometer'}, {'measure': 'Respiratory gas exchanges', 'timeFrame': '8hours', 'description': 'Measured via Douglas bag, gas content and volume'}, {'measure': 'Rate of perceived exertion', 'timeFrame': '8hours', 'description': 'using Borg scales (from 6 \\[no effort\\] to 20 \\[maximal effort\\])'}, {'measure': 'Rate of thermal sensation', 'timeFrame': '8hours', 'description': 'using -10 \\[cold\\] to +10 \\[hot\\] scale.'}, {'measure': 'Feelings of thirst, urge to urinate, GI comfort, and stomach bloatedness', 'timeFrame': '8hours', 'description': 'using scales (0 = no feeling, 10 = extreme feeling)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heat', 'plasma glucose', 'worker', 'glycemia', 'OGTT'], 'conditions': ['Plasma Glucose Following Prolonged Heat Exposure']}, 'descriptionModule': {'briefSummary': 'Occupational workers regularly perform physically demanding tasks in hot environments, exposing them to heat stress and potential dehydration. While the physiological impacts of heat exposure are well-documented, its effects on glycemic control remain less understood. Given the rising global temperatures due to climate change and the increasing prevalence of metabolic disorders such as obesity and type 2 diabetes, it is essential to investigate how heat exposure during work influences glycemic regulation. Understanding these interactions will help inform future occupational health guidelines and metabolic health recommendations in physically demanding industries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* Generally fit and healthy\n* Participate in endurance or intermittent exercise at least 3 times a week or minimum of 150 minutes moderate intensity activity per week\n\nExclusion Criteria:\n\n* Under 18 or 45 and over,\n* any morbidity or medication that might influence carbohydrate/fat metabolism (i.e., liver/renal/cardiovascular disease) or cycling ability (musculoskeletal injury etc),\n* coagulation or bleeding disorders,\n* blood-borne illness,\n* heart conditions,\n* congenital heart disease,\n* uncontrolled exercise-induced asthma,\n* smoking (including vaping),\n* allergies to the products used in the study,\n* dieting or restrained eating behaviours.\n* Females with amenorrhea would be an exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT06982612', 'briefTitle': 'Glycemic Control Following Occupational Work in a Hot Environment', 'organization': {'class': 'OTHER', 'fullName': 'Loughborough University'}, 'officialTitle': 'Glycemic Control Following Occupational Work in a Hot Environment', 'orgStudyIdInfo': {'id': 'LEON21544'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hot condition', 'description': 'Light exercise in a hot environment with ad libitum water intake', 'interventionNames': ['Other: Hot environment']}, {'type': 'EXPERIMENTAL', 'label': 'Temperate condition', 'description': 'Light exercise in a temperate environment with ad libitum water intake', 'interventionNames': ['Other: Temperate condition']}], 'interventions': [{'name': 'Hot environment', 'type': 'OTHER', 'description': 'Participants exercising in a 36 degrees celsius environment', 'armGroupLabels': ['Hot condition']}, {'name': 'Temperate condition', 'type': 'OTHER', 'description': 'Participants exercising in a 18 degrees celsius environment', 'armGroupLabels': ['Temperate condition']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Stephen A Mears, PhD', 'role': 'CONTACT', 'email': 's.a.mears@lboro.ac.uk', 'phone': '+44 1509 226391'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loughborough University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr - Senior lecturer', 'investigatorFullName': 'Stephen Mears', 'investigatorAffiliation': 'Loughborough University'}}}}