Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-24 @ 6:17 AM
Study NCT ID:
NCT03660332
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2018-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of an Acute Increase in Plasma IL-6 on Glucose Tolerance When a Meal is Administered Intraduodenally
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-23', 'studyFirstSubmitDate': '2018-09-04', 'studyFirstSubmitQcDate': '2018-09-05', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The paracetamol uptake', 'timeFrame': '0-14 days', 'description': 'paracetamol blood levels (mmol/l) on both study days. The paracetamol absorbance will be compared between the 2 study days.'}], 'secondaryOutcomes': [{'measure': 'GLP-1 secretion', 'timeFrame': '0-14 days', 'description': 'Active GLP-1 blood levels on both study days. The levels on the 2 study days will be compared.'}, {'measure': 'Glucagon secretion', 'timeFrame': '0-14 days', 'description': 'Glucagon blood levels on both study days. The levels on the 2 study days will be compared.'}, {'measure': 'Insulin levels', 'timeFrame': '0-14', 'description': 'Insulin blood levels on both study days. The levels on the 2 study days will be compared.'}, {'measure': 'Glucose', 'timeFrame': '0-14', 'description': 'Plasma glucose levels on both study days. The levels on the 2 study days will be compared.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postprandial Glucose Homeostasis']}, 'referencesModule': {'references': [{'pmid': '29731416', 'type': 'RESULT', 'citation': 'Lang Lehrskov L, Lyngbaek MP, Soederlund L, Legaard GE, Ehses JA, Heywood SE, Wewer Albrechtsen NJ, Holst JJ, Karstoft K, Pedersen BK, Ellingsgaard H. Interleukin-6 Delays Gastric Emptying in Humans with Direct Effects on Glycemic Control. Cell Metab. 2018 Jun 5;27(6):1201-1211.e3. doi: 10.1016/j.cmet.2018.04.008. Epub 2018 May 3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate and clarify whether the effect of IL-6 on glucose tolerance and insulin secretion are secondary to the changes in gastric emptying.\n\nThe literature provides no information regarding a role for interleukin-6 (IL-6) in the regulation of beta cell function (glucose or meal-stimulated insulin secretion) in humans. Previous studies infusing IL-6 into humans have primarily focused on insulin action and the effects on peripheral insulin sensitivity whereas a potential effect on insulin secretion has been neglected.\n\nWe have demonstrated that an acute increase in IL-6, obtained by a single bolus of IL-6, potentiated glucose-induced insulin secretion in a glucagon-like peptide-1 (GLP-1) dependent manner in mice1. In mice, IL-6 enhanced insulin secretion in a dose- and glucose-dependent manner, along with increasing concentrations of GLP-1. Interleukin-6 had no effect on insulin secretion in GLP-1 receptor knock-out mice or in mice treated with the GLP-1 receptor antagonist. Thus, in mice, GLP-1 has proven an essential mediator of IL-6 actions on beta cell function.\n\nImportantly, a single bolus of IL-6 also significantly increased glucose-stimulated insulin secretion in several mouse models of obesity and diabetes (diet-induced obesity, the ob/ob and the db/db mouse).\n\nOwn data show that an infusion of IL-6 causes a significant delay in the rate of gastric emptying (GE) after a mixed meal in healthy young men. Data showed that this delay in GE is associated with much improved glucose tolerance and insulin secretion (unpublished data).\n\nIn the present study we wish to investigate whether the beneficial effects of IL-6 on postprandial glucose tolerance and insulin secretion are dependent on a delay in gastric emptying. We will bypass the ventricle and infuse a mixed meal directly into the duodenum of healthy young men.\n\nThis study has the potential to show that the known effect of IL-6 on postprandial glucose tolerance is dependent on a delayed GE.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 35 years\n* Healthy (based on screening)\n\nExclusion Criteria:\n\n* Smoking\n* BMI \\< 18 and \\> 25 kg/m2\n* Evidence of severe thyroid, liver, lung, heart or kidney disease'}, 'identificationModule': {'nctId': 'NCT03660332', 'acronym': 'DUIL-6', 'briefTitle': 'The Effect of an Acute Increase in Plasma IL-6 on Glucose Tolerance When a Meal is Administered Intraduodenally', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'The Effect of an Acute Increase in Plasma IL-6 on Glucose Tolerance When a Meal is Administered Intraduodenally', 'orgStudyIdInfo': {'id': 'H-16036538'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IL-6 infusion', 'description': 'Healthy young men will receive IL-6 infusion', 'interventionNames': ['Procedure: Infusion of a liquid meal intraduodenally']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo infusion', 'description': 'Healthy young men will receive saline infusion', 'interventionNames': ['Procedure: Infusion of a liquid meal intraduodenally']}], 'interventions': [{'name': 'Infusion of a liquid meal intraduodenally', 'type': 'PROCEDURE', 'description': 'Infusion of IL-6/NaCL before a liquid meal intraduodenally', 'armGroupLabels': ['IL-6 infusion', 'Placebo infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet, Centre of Inflammation and Metabolism (CIM) Centre for Physical Activity Research (CFAS)', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Bente K Pedersen, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CFAS, Rigshospitalet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD student', 'investigatorFullName': 'Louise Lang Lehrskov', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}