Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-02-20 @ 6:23 PM
Study NCT ID:
NCT03285750
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2013-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expression of G-protein Coupled Receptor 120 Receptor in Adipose Tissue of German Diabetes Center Cohort Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'SNP Genotyping of GPR120'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-13', 'studyFirstSubmitDate': '2013-08-13', 'studyFirstSubmitQcDate': '2017-09-13', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GPR120 expression in adipose tissue', 'timeFrame': 'Expression measured at baseline (day 1)', 'description': 'GPR expression is measured in adipose tissue of recently diagnosed type 2 diabetic patients and age- and BMI-matched normoglycemic controls'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GPR120', 'Adipose tissue', 'Type 2 diabetes'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'G-protein coupled receptor 120 (GPR120) is a G-protein-coupled receptor whose endogenous ligands have been identified as long-chain fatty acids. Recently, it has been shown that GPR120 expression in human adipose tissue is higher in obese than in lean individuals. Interestingly, a GPR120 deficient mouse model presents an unfavorable phenotype when fed a high-fat diet with obesity, glucose intolerance and fatty liver, characteristics also found in type 2 diabetes (T2D).\n\nMoreover, in obese subjects, a single nucleotide polymorphism (R270H) has been identified that inhibits GPR120 signaling activity.\n\nThe investigators now want to investigate if GPR120 expression in adipose tissue may be altered in patients with T2D compared to non-diabetic subjects and might contribute to diabetes-associated metabolic changes. Additionally, the investigators want to assess the frequency of the R270H mutant in T2D.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with recently diagnosed type 2 diabetes (up to one year from diagnosis) and age- and weight-matched normoglycemic controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus / normoglycemia\n* BMI \\< 27,5 or \\> 30 kg/m2\n* Age 20 - 69 years\n\nExclusion Criteria:\n\n* severe chronic diseases\n* anemia\n* medication altering fatty acid metabolism'}, 'identificationModule': {'nctId': 'NCT03285750', 'acronym': 'GPR120', 'briefTitle': 'Expression of G-protein Coupled Receptor 120 Receptor in Adipose Tissue of German Diabetes Center Cohort Subjects', 'organization': {'class': 'OTHER', 'fullName': 'German Diabetes Center'}, 'officialTitle': 'Expression of GPR120 Receptor in Adipose Tissue of Type 2 Diabetic Subjects', 'orgStudyIdInfo': {'id': 'GPR120 study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic group', 'description': 'Patients with recently diagnosed type 2 diabetes'}, {'label': 'Controls', 'description': 'Age- and BMI-matched normoglycemic subjects'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'German Diabetes Center', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Michael Roden, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'German Diabetes Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Diabetes Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}