Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
Study NCT ID:
NCT04613700
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2020-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Secretin on the Energy Homeostasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012633', 'term': 'Secretin'}], 'ancestors': [{'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'randomised, double-blinded, placebo-controlled, cross-over study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2020-10-19', 'studyFirstSubmitQcDate': '2020-11-02', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food intake on ad libitum meal', 'timeFrame': '300 minutes', 'description': 'Kilojoule'}, {'measure': 'Duration of ad libitum meal', 'timeFrame': '300 minutes', 'description': 'Duration in minutes'}], 'secondaryOutcomes': [{'measure': 'Water intake during ad libitum meal', 'timeFrame': '300 minutes', 'description': 'mL'}, {'measure': 'resting energy expenditure', 'timeFrame': 'Baseline, 90 minutes and 270 minutes', 'description': 'Indirect calorimetry of respiration'}, {'measure': 'Supraclavicular Brown adipose activity', 'timeFrame': '-15 to 15 , 90 and 270 minutes', 'description': 'Evaluated by neck skin temperature assessed using a non-invasive thermal imaging camera)'}, {'measure': 'Appetite and satiety sensations (assessed by VASs),', 'timeFrame': 'Every 15 minutes after infusion, until time-point 90, hereafter every 30 minutes', 'description': 'Visual analogue scales with a scale of 1-10 (Direction of scale varies)'}, {'measure': 'Heart rate', 'timeFrame': 'every 15 minutes from from -15 to 300 minutes', 'description': 'heart rate .'}, {'measure': 'systolic blood pressure', 'timeFrame': 'every 15 minutes from from -15 to 300 minutes', 'description': 'Systolic blood pressure'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'every 15 minutes from from -15 to 300 minutes', 'description': 'Diastolic blood pressures'}, {'measure': 'Gallbladder motility', 'timeFrame': 'Timepoint -30, 10,20,45,60,75,90,120,210,300 minutes', 'description': 'Gallbladder motility measured by Ultrasound'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Metabolic Disease', 'Diabetes', 'Adiposity']}, 'referencesModule': {'references': [{'pmid': '39556772', 'type': 'DERIVED', 'citation': 'Heimburger SMN, Bentzen MJ, Kizilkaya HS, Hartmann B, Holst JJ, Rosenkilde MM, Dela F, Hansen SH, Rehfeld JF, Christensen MB, Knop FK. Secretin infusion decreases food intake in healthy men-a randomized, placebo-controlled, double-blind, crossover study. Eur J Endocrinol. 2024 Nov 27;191(6):545-557. doi: 10.1093/ejendo/lvae147.'}]}, 'descriptionModule': {'briefSummary': 'As of last year, new insight into the function of secretin was brought about as rodent studies showed secretin to possess potential body weight-regulating effects. In these studies, secretin was shown to increase non-shivering thermogenesis in brown adipose tissue (BAT), decrease meal size and promote meal discontinuation. The mechanisms behind these regulatory effect of secretin on energy homeostasis are unclear,', 'detailedDescription': 'Secretin was - as the first hormone - identified in 19021, but was not isolated until the 1960s. Secretin is produced in and secreted form small intestinal S cells. In the 1970s, the primary endocrine effects of secretin were unequivocally confirmed, namely potentiation of bicarbonate and pepsin secretion from the pancreas as well as stimulation of bile production in the liver. In the 1990s, the biosynthesis of secretin was delineated and its receptor was discovered. In the 2000s the pancreatic regulation of intestinal pH was shown to be secretin-mediated. As of last year, new insight into the function of secretin was brought about as rodent studies showed secretin to possess potential body weight-regulating effects. In these studies, secretin was shown to increase non-shivering thermogenesis in brown adipose tissue (BAT), decrease meal size and promote meal discontinuation.\n\nThe primary aim of this study is to evaluate the effect of a 5-hour intravenous infusion with the naturally occurring hormone secretin on ad libitum food intake (primary endpoint) compared to a double-blinded placebo (isotonic saline) infusion in 25 healthy young males.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 75 years\n* Body mass index between 18.5 and 27.5 kg/m2\n* Informed consent\n* Body weight above 50 kg\n\nExclusion Criteria:\n\n* Anaemia (blood haemoglobin below normal range)\n* Known liver disease and/or alanine aminotransferase and/or aspartate transaminase \\> 2 times upper normal values\n* Nephropathy (serum creatinine above normal range and/or albuminuria)\n* Clinically significant kidney function impairment or other laboratory findings leading to the diagnosis of clinically relevant disorders (thyroid dysfunction, anaemia etc)\n* Any physical or psychological condition that the investigators feel would interfere with trial participation'}, 'identificationModule': {'nctId': 'NCT04613700', 'acronym': 'THE-ROSE', 'briefTitle': 'The Role of Secretin on the Energy Homeostasis', 'organization': {'class': 'OTHER', 'fullName': 'Steno Diabetes Center Copenhagen'}, 'officialTitle': 'The Role of Secretin on the Energy Homeostasis', 'orgStudyIdInfo': {'id': 'The-ROSE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Secretin', 'interventionNames': ['Drug: Secretin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Secretin', 'type': 'DRUG', 'description': 'Native hormone', 'armGroupLabels': ['Secretin']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Herlev- Gentofte Hospital, Center for Clinical Metabolic Research', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'overallOfficials': [{'name': 'Filip K Knop, Professor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gentofte Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steno Diabetes Center Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}