Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-03-06 @ 10:10 PM
Study NCT ID:
NCT03241303
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2017-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delineation of the Role of Glucagon-like Peptide-1 Signalling in Relation to Increased Carbohydrate Content in the Distal Small Intestines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020909', 'term': 'Acarbose'}, {'id': 'C083773', 'term': 'exendin (9-39)'}], 'ancestors': [{'id': 'D014312', 'term': 'Trisaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-25', 'studyFirstSubmitDate': '2017-08-02', 'studyFirstSubmitQcDate': '2017-08-04', 'lastUpdatePostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma glucose', 'timeFrame': '240 min', 'description': 'The primary outcome is the difference between the effect of increased carbohydrate content in the distal part of the small intestine (obtained by inhibiting alpha-glucosidase with acarbose) on postprandial glucose tolerance (as assessed by area under curve (AUC) for plasma glucose during a standardised liquid mixed meal test) with and without blockade of GLP-1 signalling by exendin(9-39).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glp-1', 'alpha-glucosidase inhibitor', 'acarbose'], 'conditions': ['Glucose Metabolism Disorders']}, 'descriptionModule': {'briefSummary': 'Investigation of GLP-1 signalling in the glucose-lowering effect of increased carbohydrate content in the distal small intestines induced by alpha-glucosidase inhibition during meal ingestion in patients with type 2 diabetes', 'detailedDescription': 'The primary aim of the study is to investigate whether GLP-1 released as a result of increased carbohydrate content in the distal and L cell-rich part of the small intestine after a meal affects postprandial plasma glucose levels in patients with type 2 diabetes. This will be done by applying an alpha-glucosidase inhibitor (to increase the postprandial carbohydrate content in the distal small intestine) and the specific GLP-1 receptor antagonist exendin(9-39) (to isolate any GLP-1-mediated effects) during meal tests in patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes for at least three months (diagnosed according to the criteria of the World Health Organization (WHO)) treated with metformin monotherapy\n* Caucasian ethnicity\n* Normal haemoglobin\n* Age \\>18 years\n* BMI \\>23 kg/m2 and \\<35 kg/m2\n* Informed and written consent\n\nExclusion Criteria:\n\n* Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \\>2 times normal values) or history of hepatobiliary disorder\n* Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery\n* Reduced kidney function or nephropathy (estimated glomerular filtration rate (eGFR) \\<60 ml/min/1.73 m2 (based on serum creatinine) and/or albuminuria\n* Treatment with medicine that cannot be paused for 12 hours\n* Intake of antibiotics two months prior to study\n* Treatment with glucose-lowering drugs other than metformin\n* Hypo- and hyperthyroidism\n* Treatment with oral anticoagulants\n* Active or recent malignant disease\n* Any treatment or condition requiring acute or sub-acute medical or surgical intervention\n* Lack of effective birth control in premenopausal women\n* Positive pregnancy test on study days in premenopausal women\n* Pregnancy\n* Women who are breastfeeding\n* Any condition considered incompatible with participation by the investigators\n* If the subjects receive any antibiotic treatment while included in the study they will be excluded'}, 'identificationModule': {'nctId': 'NCT03241303', 'acronym': 'AlfaEx', 'briefTitle': 'Delineation of the Role of Glucagon-like Peptide-1 Signalling in Relation to Increased Carbohydrate Content in the Distal Small Intestines', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'The Role of Glucagon-like Peptide-1 Receptor Signalling in the Glucose-lowering Effect of Increased Carbohydrate Content in the Distal Small Intestines After Meal Ingestion in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'H-17007893'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acarbose', 'description': '50 mg and 100 mg glucobay tablets. 2 weeks. Other name: Precose', 'interventionNames': ['Drug: Acarbose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Oral tablets', 'description': '180 mg. 2 weeks.', 'interventionNames': ['Drug: Placebo Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Exendin (9-39)', 'description': 'Infusion of GLP-1 receptor antagonist as a study tool to block GLP-1 activity on experimental day.', 'interventionNames': ['Drug: Exendin (9-39)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placbo Saline', 'description': '9 mg/ml placebo saline infusion on experimental day.', 'interventionNames': ['Drug: Placebo Saline']}], 'interventions': [{'name': 'Acarbose', 'type': 'DRUG', 'otherNames': ['Glucobay, Precose'], 'description': 'Glucobay tablets on experimental day.', 'armGroupLabels': ['Acarbose']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'Placebo tablets on experimental day.', 'armGroupLabels': ['Placebo Oral tablets']}, {'name': 'Exendin (9-39)', 'type': 'DRUG', 'otherNames': ['Ex(9-39)'], 'description': 'Infusion of GLP-1 receptor antagonist as a study tool to block GLP-1 activity on experimental day.', 'armGroupLabels': ['Exendin (9-39)']}, {'name': 'Placebo Saline', 'type': 'DRUG', 'description': '9 mg/ml placebo saline infusion on experimental day.', 'armGroupLabels': ['Placbo Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Center for Diabetesresearch', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'overallOfficials': [{'name': 'Filip K Knop, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Gentofte, Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Bachelor of Science', 'investigatorFullName': 'Niels Bjørn Dalsgaard', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}