Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-31 @ 2:36 AM
Study NCT ID:
NCT01677104
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2012-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Microvascular Function of GLP-1 and Its Analogues
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D000077270', 'term': 'Exenatide'}, {'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-12', 'studyFirstSubmitDate': '2012-08-29', 'studyFirstSubmitQcDate': '2012-08-30', 'lastUpdatePostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'skin blood flow', 'timeFrame': '3 hours', 'description': 'skin blood flow will be assessed before and after microinjection of GLP-1 or its analogues and the injection site monitored and compared to sites injected with placebo'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['GLP-1', 'DPP-IV inhibitor', 'microcirculation', 'Exenatide', 'Liraglutide', 'Linagliptin'], 'conditions': ['Type 2 Diabetes', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '31203378', 'type': 'DERIVED', 'citation': 'Aung MM, Slade K, Freeman LAR, Kos K, Whatmore JL, Shore AC, Gooding KM. Locally delivered GLP-1 analogues liraglutide and exenatide enhance microvascular perfusion in individuals with and without type 2 diabetes. Diabetologia. 2019 Sep;62(9):1701-1711. doi: 10.1007/s00125-019-4918-x. Epub 2019 Jun 16.'}]}, 'descriptionModule': {'briefSummary': 'Incretins have become a successful drug target in the repertoire of medications used for the treatment of type 2 diabetes. However little is known about a potential benefit of GLP-1 on the vascular system in humans, independent of their glucose lowering actions and data are only derived from ex vivo studies in animals. Particularly little is known about clinically relevant benefits of GLP-1 and its analogues on the microvascular system of individuals with type 2 diabetes.\n\nThe vascular effect could be medicated by endogenous GLP-1 (9,36) amide, the breakdown product of GLP-1 (7,36) amide which has a low affinity for the GLP-1 receptor. The investigators hypothesis is that the co-administration of DPP-IV inhibitors will lack the beneficial effects of GLP-1 on the vascular system as GLP-1 (9,36) amide will not be produced by the body.\n\nThe study aims to examine the response of GLP-1 and its analogues on small blood vessels and examine the effect of the addition of DPP-IV inhibition in healthy lean individuals, obese individuals and subjects with Type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Lean BMI ≤ 25.0 kg/m2\n* Obese BMI ≥30.0kg/m2\n* Non diabetic subjects and subjects with Type 2 diabetes on stable medication for at least 3 months\n\nExclusion Criteria:\n\n* cardiovascular disease\n* Raynaud's disease\n* current treatment with any anti-hypertensive\n* lipid lowering therapies\n* severe hepatic impairment\n* pregnancy and lactation\n* subjects with Type 2 diabetes on insulin therapy\n* subjects with Type 2 diabetes on sulphonylureas\n* subjects with Type 2 diabetes on incretin based therapies\n* subjects with Type 2 diabetes and peripheral vascular disease\n* subjects with Type 2 diabetes and history of advanced retinopathy\n* subjects with Type 2 diabetes and advanced nephropathy\n* subjects with Type 2 diabetes with uncontrolled diabetes (HbA1c \\> 8.5%)"}, 'identificationModule': {'nctId': 'NCT01677104', 'briefTitle': 'The Microvascular Function of GLP-1 and Its Analogues', 'organization': {'class': 'OTHER', 'fullName': 'Royal Devon and Exeter NHS Foundation Trust'}, 'officialTitle': 'The Microvascular Function of GLP-1 and Its Analogues in Humans, in Vivo: the Role of DPP-IV Inhibition', 'orgStudyIdInfo': {'id': '11/SW/0195'}, 'secondaryIdInfos': [{'id': '1204620', 'type': 'OTHER', 'domain': 'Research and Development'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DPP-IV inhibitor', 'description': 'Linagliptin 5mg (Tradjenta) before microinjection of GLP-1 and its analogues', 'interventionNames': ['Drug: GLP-1', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo pill', 'description': 'One placebo tablet before microinjection', 'interventionNames': ['Drug: GLP-1', 'Drug: Placebo']}], 'interventions': [{'name': 'GLP-1', 'type': 'DRUG', 'otherNames': ['native GLP-1(7,36)', 'Exenatide (Byetta)', 'Liraglutide (Vicotza)'], 'description': 'GLP-1 and its analogues will be compared with placebo with and without prior DPP-IV inhibition', 'armGroupLabels': ['DPP-IV inhibitor', 'Placebo pill']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['DPP-IV inhibitor', 'Placebo pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EX2 5AX', 'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'Diabetes and Vascular Center', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}], 'overallOfficials': [{'name': 'Katarina Kos, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institue of Biomedical and Clinical Sciences, Peninsula Medical School, University of Exeter'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Katarina Kos', 'class': 'OTHER'}, 'collaborators': [{'name': 'Diabetes UK', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Consultant Physician and Senior Lecturer', 'investigatorFullName': 'Katarina Kos', 'investigatorAffiliation': 'Royal Devon and Exeter NHS Foundation Trust'}}}}