Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-03 @ 10:41 AM
Study NCT ID:
NCT03522792
Status:
UNKNOWN
Last Update Posted:
2019-11-12
First Post:
2017-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurotensin - an Important Regulator of Appetite in Humans?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009496', 'term': 'Neurotensin'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will not be informed of the nature of the infusion they are administered on any of the study days. The investigator will be provided with an infusion (either isotonic saline with HSA or isotonic salin with HSA + neurotensin) prepared by a designated colleague'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants will be studied on multiple occasions (5 days) in a randomised and double blinded fashion. One day will serve as an acclimatization day.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-07', 'studyFirstSubmitDate': '2017-12-14', 'studyFirstSubmitQcDate': '2018-04-30', 'lastUpdatePostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ad libitum food intake (ad libitum days)', 'timeFrame': '60 min', 'description': 'Neurotensin (NT) and saline will be infused on two occasions in random order, double blinded. After 1h of infusion an ad libitum meal will be served. When the meal is completed food intake will be determined by weighing the leftovers.'}, {'measure': 'Ad libitum food intake (liquid meal + ad libitum days)', 'timeFrame': '240 min', 'description': 'Neurotensin (NT) and saline will be infused on two occasions in random order, double blinded. 1h into the infusions a standardized liquid mixed meal will be ingested. After another 180 min an ad libitum meal will be served. When the meal is completed food intake will be determined by weighing the leftovers.'}], 'secondaryOutcomes': [{'measure': 'Appetite and gastrointestinal sensations (ad libitum days)', 'timeFrame': '-60, -15, 15, 30, 60, 90, 120 min', 'description': 'Using visual analogue scales (VAS) the effect of infusions and meals will be documented.\n\nAd libitum meals will also be evaluated using VAS.'}, {'measure': 'Appetite and gastrointestinal sensations (liquid meal + ad libitum days)', 'timeFrame': '-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min', 'description': 'Using visual analogue scales (VAS) the effect of infusions and meals will be documented.\n\nAd libitum meals will also be evaluated using VAS.'}, {'measure': 'Plasma glucose (ad libitum days)', 'timeFrame': '-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min', 'description': 'Bed-side measurements of plasma glucose'}, {'measure': 'Plasma glucose (liquid meal + ad libitum days)', 'timeFrame': '-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min', 'description': 'Bed-side measurements of plasma glucose'}, {'measure': 'Neurotensin (ad libitum days)', 'timeFrame': '-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min', 'description': 'Plasma analysis'}, {'measure': 'Neurotensin (liquid meal + ad libitum days)', 'timeFrame': '-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min', 'description': 'Plasma analysis'}, {'measure': 'Insulin (liquid meal + ad libitum days)', 'timeFrame': '-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min', 'description': 'Serum analysis'}, {'measure': 'Bile acids (ad libitum days)', 'timeFrame': '-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min', 'description': 'Plasma analysis'}, {'measure': 'bile acids (liquid meal + ad libitum days)', 'timeFrame': '-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min', 'description': 'Plasma analysis'}, {'measure': 'Ghrelin (ad libitum days)', 'timeFrame': '-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min', 'description': 'Plasma analysis'}, {'measure': 'Ghrelin (liquid meal + ad libitum days)', 'timeFrame': '-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min', 'description': 'Plasma analysis'}, {'measure': 'Glucagon-like peptide-1 (GLP-1) (ad libitum days)', 'timeFrame': '-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min', 'description': 'Plasma analysis'}, {'measure': 'Glucagon-like peptide-1 (GLP-1) (liquid meal + ad libitum days)', 'timeFrame': '-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min', 'description': 'Plasma analysis'}, {'measure': 'Glucose-dependent insulinotropic polypeptide (GIP) (liquid meal + ad libitum days)', 'timeFrame': '-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min', 'description': 'Plasma analysis'}, {'measure': 'Peptide YY (PYY) (liquid meal + ad libitum days)', 'timeFrame': '-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min', 'description': 'Plasma analysis'}, {'measure': 'Paracetamol (liquid meal + ad libitum days)', 'timeFrame': '-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min', 'description': 'Serum analyses'}, {'measure': 'Pancreatic polypeptide (PP) (liquid meal + ad libitum days)', 'timeFrame': '-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min', 'description': 'Plasma analysis'}, {'measure': 'Pancreatic polypeptide (PP) (ad libitum days)', 'timeFrame': '-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min', 'description': 'Plasma analysis'}, {'measure': 'Cholecystokinin (CCK) (ad libitum days)', 'timeFrame': '-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min', 'description': 'Plasma analysis'}, {'measure': 'Cholecystokinin (CCK) (liquid meal + ad libitum days)', 'timeFrame': '-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min', 'description': 'Plasma analysis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['food intake', 'appetite', 'obesity treatment', 'neurotensin', 'gastrointestinal', 'peptide'], 'conditions': ['Physiology - Regulation of Appetite and Food Intake']}, 'descriptionModule': {'briefSummary': 'Neurotensin (NT) is a gut peptide released postprandially from the small intestine. It is known to exert a range of enterogastrone effects and in animal models it reduces food intake when administered by parenteral routes.\n\nThis study investigates whether the anorexic effects of NT suggested by animal studies can be translated.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age = or above 18 years\n* normal haemoglobin levels\n* male\n* informed consent\n\nExclusion Criteria:\n\n* Diabetes mellitus (fasting plasma glucose or HbA1c)\n* Familiy history of diabetes mellitus\n* Intestinal disease (incl e.g. inflammatory bowel disease and malabsorbtion)\n* Family history of inflammatory bowel disease\n* Previous intestinal resection\n* Body mass index (BMI) over 25 kg/m2\n* Smoker\n* Nephropathy (S-creatinine\\> 130 μM)\n* Liver disease (ALAT and/or ASAT \\> 2 × upper normal limit)'}, 'identificationModule': {'nctId': 'NCT03522792', 'acronym': 'NIRAH', 'briefTitle': 'Neurotensin - an Important Regulator of Appetite in Humans?', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'The Effect of Neurotensin on Appetite, Food Intake, Blood Glucose Regulation, Hormone Secretion, and the Degradation of Neurotensin in Vivo', 'orgStudyIdInfo': {'id': 'Neurotensin BMI/HH 2017 UCPH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saline + ad libitum meal', 'description': 'This will serve as the placebo / control day for the NT + ad libitum meal study day.', 'interventionNames': ['Other: Saline', 'Other: Ad libitum meal']}, {'type': 'EXPERIMENTAL', 'label': 'NT + ad libitum meal', 'description': 'Neurotensin (NT) infusion followed by an ad libitum meal to study the effect of NT on ad libitum food intake.', 'interventionNames': ['Other: Neurotensin', 'Other: Ad libitum meal']}, {'type': 'EXPERIMENTAL', 'label': 'Saline + liquid meal + ad libitum meal', 'description': 'Saline infusion followed a standardized liquid mixed meal followed by an ad libitum meal. This will serve as the placebo / control day for the NT + standardized liquid mixed meal + ad libitum meal study day. Investigating the effect of NT on the second meal effect.', 'interventionNames': ['Other: Saline', 'Other: Ad libitum meal', 'Other: Liquid meal']}, {'type': 'EXPERIMENTAL', 'label': 'NT + liquid meal + ad libitum meal', 'description': 'NT infusion followed a standardized liquid mixed meal followed by an ad libitum meal. This study day aims to study the effect of NT on the second meal effect.', 'interventionNames': ['Other: Neurotensin', 'Other: Ad libitum meal', 'Other: Liquid meal']}, {'type': 'EXPERIMENTAL', 'label': 'Neurotensin', 'description': 'Acclimatization day', 'interventionNames': ['Other: Neurotensin', 'Other: Ad libitum meal']}], 'interventions': [{'name': 'Neurotensin', 'type': 'OTHER', 'description': 'Intravenous infusion of neurotensin', 'armGroupLabels': ['NT + ad libitum meal', 'NT + liquid meal + ad libitum meal', 'Neurotensin']}, {'name': 'Saline', 'type': 'OTHER', 'description': 'Intravenous infusion of saline', 'armGroupLabels': ['Saline + ad libitum meal', 'Saline + liquid meal + ad libitum meal']}, {'name': 'Ad libitum meal', 'type': 'OTHER', 'description': 'Participants will be served a large meal serving. They will be instructed to eat until they do not feel hungry anymore.', 'armGroupLabels': ['NT + ad libitum meal', 'NT + liquid meal + ad libitum meal', 'Neurotensin', 'Saline + ad libitum meal', 'Saline + liquid meal + ad libitum meal']}, {'name': 'Liquid meal', 'type': 'OTHER', 'description': 'A standardized mixed liquid meal will be ingested to stimulate endogenous peptide hormone release', 'armGroupLabels': ['NT + liquid meal + ad libitum meal', 'Saline + liquid meal + ad libitum meal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'state': 'Capital', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Copenhagen University Hospital, Hvidovre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Simon Veedfald', 'investigatorAffiliation': 'University of Copenhagen'}}}}