[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586392":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":48,"centralContacts":53,"locations":62,"responsibleParty":83,"collaborators":86,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":10,"studyType":102,"phases":10,"briefSummary":103,"conditions":104,"keywords":108,"overallStatus":65,"whyStopped":10,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Hywel Dda Health Board","OTHER",[8,15,19,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 - No diabetic retinopathy or maculopathy",null,"Group 1 - Patients with type 2 DM but No diabetic retinopathy or maculopathy",[13,14],"Other: Blood draw for the laboratory assessment","Other: Urine sample",{"label":16,"type":10,"description":17,"interventionNames":18},"Group 2 - Mild preproliferative DR","Group 2 - Patients with Type 2 diabetes and Mild preproliferative DR",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Group 3 - Moderate Pre-proliferative DR","Group 3 - Patients with type 2 diabetes and Moderate Pre-proliferative DR",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Group 4 - Severe pre-proliferative DR","Group 4 - Patients with type 2 diabetes and Severe pre-proliferative DR",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Group 5 - Proliferative DR","Group 5 - Patients with type 2 diabetes and Proliferative DR",[13,14],{"label":32,"type":10,"description":33,"interventionNames":34},"Group 6 - DMO with any degree of DR and no prior treatment","Group 6 - Patients with type 2 diabetes and DMO with any degree of DR and no prior treatment",[13,14],[36,42],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Blood draw for the laboratory assessment","Blood plasma collection for for lipidomic and metabolomic analysis",[9,16,20,24,28,32],[41],"Blood sample collection for lipidomics and metabolomics",{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Urine sample","Urine sampling for aqueous metabolomics",[9,16,20,24,28,32],[47],"Urine sample for metabolomics",[49],{"name":50,"affiliation":51,"role":52},"Francis WB Sanders, MB BChir PhD FRCOphth","Hywel Dda University Health Board","PRINCIPAL_INVESTIGATOR",[54,58],{"name":50,"role":55,"phone":56,"phoneExt":10,"email":57},"CONTACT","+447717171199","francis.sanders@wales.nhs.uk",{"name":59,"role":55,"phone":60,"phoneExt":10,"email":61},"Eirini Skiadaresi","+447427120616","eirini.skiadaresi@wales.nhs.uk",[63],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Prince Philip Hospital","RECRUITING","Llanelli","Wales","SA14 8QF","United Kingdom","UK",{"type":72,"coordinates":73},"Point",[74,75],-4.16191,51.68195,{"lat":75,"lon":74},[78,80,82],{"name":50,"role":55,"phone":79,"phoneExt":10,"email":57},"07717171199",{"name":59,"role":55,"phone":81,"phoneExt":10,"email":61},"07427120616",{"name":50,"role":52,"phone":10,"phoneExt":10,"email":10},{"type":52,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Frank Sanders","Honorary Research Fellow",[87],{"name":88,"class":6},"University of Aberdeen","100586392","investigating-the-metabolic-and-lipidomic-profiles-that-are-associated-with-varying-grades-of-diabetic-maculopathy-and-retinopathy-in-south-wales-100586392",false,"NCT06914778","Investigating the Metabolic and Lipidomic Profiles That Are Associated With Varying Grades of Diabetic Maculopathy and Retinopathy in South Wales","IMLADRIS","Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes mellitus\n* Male or female aged 18 - 80 inclusive\n\nExclusion Criteria:\n\n* Participant unable or unwilling to consent to inclusion in the study\n* Prior treatment with intravitreal therapies for DMO\n* Potential participant with a known infective disease that may put the study team at risk (eg. TB, HIV, hepatitis)\n* Age 17 yo or less or 81 yo or older\n* Known underlying genetic condition affecting lipid metabolism","ALL","18 Years","80 Years",{"count":100,"type":101},120,"ESTIMATED","OBSERVATIONAL","Diabetes mellitus is a disorder of sugar and fat metabolism which results in damage to the small blood vessels in various organs, this includes the retina - the part of the eye that processes light into a nerve impulse. This leads to damage and blindness via various different mechanisms that are not fully understood.\n\nIn this study the objective is to recruit people with diabetes and various stages of diabetic eye disease and measure a large number of different chemicals within the blood that might be associated with damage and dysfunction within the retina. Additionally, it will examine the different bacteria within the gut that might affect disease in the eye via chemicals circulating in the blood. This will require participants to have blood samples taken and to provide urine samples. The blood will be analysed with specialised instruments to identify specific molecules circulating within the blood. Participants will also need to allow researchers to look at their medical records, previous photographs and specialist scans of the back of the eye to grade their diabetic retinopathy. This will allow us to identify potential ways in which these could be targeted for future benefit for people with diabetes to hopefully prevent deterioration of their vision.",[105,106,107],"Diabetic Retinopathy (DR)","Diabetic Retinopathy Associated With Type 2 Diabetes Mellitus","Diabetic Macular Edema (DME)",[109,110,111,112,113],"diabetic retinopathy","lipidomics","ophthalmology","diabetic maculopathy","metabolomics","2025-04-08",{"date":116,"type":117},"2025-04-10","ACTUAL",{"date":119,"type":117},"2025-03-31",{"date":121,"type":101},"2030-01-01",{"name":5,"class":6},1]