[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100354850":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":49,"collaborators":19,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":19,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":19,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Cambridge University Hospitals NHS Foundation Trust","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm Study","EXPERIMENTAL","Total Diet Replacement for 12 weeks, food reintroduction 6 weeks",[13],"Dietary Supplement: Total Dietary Replacement",[15],{"type":16,"name":17,"description":17,"armGroupLabels":18,"otherNames":19},"DIETARY_SUPPLEMENT","Total Dietary Replacement",[9],null,[21],{"name":22,"affiliation":23,"role":24},"David Savage","Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Mandour O Mandour","CONTACT","01223768625","mom30@cam.ac.uk",[32],{"facility":33,"status":34,"city":35,"state":19,"zip":19,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Cambridge University Hospital NHS Foundation Trust","RECRUITING","Cambridge","United Kingdom","UK",{"type":39,"coordinates":40},"Point",[41,42],0.11667,52.2,{"lat":42,"lon":41},[45,48],{"name":46,"role":28,"phone":47,"phoneExt":19,"email":30},"Mandour O Mandour, MBBS, MRCP","+441233768455",{"name":22,"role":24,"phone":19,"phoneExt":19,"email":19},{"type":24,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Mandour Omer Mandour","Wellcome Trust Senior Clinical Fellow","100354850","low-energy-diet-and-familial-partial-lipodystrophy-100354850",false,"NCT03900286","Low Energy Diet and Familial Partial Lipodystrophy","Evaluating the Therapeutic Efficacy and Metabolic Impact of a Low Energy Diet (LED) in People With Familial Partial Lipodystrophy and Diabetes","Inclusion Criteria:\n\n* Familial Partial Lipodystrophy\n* Age \\>= 18 yrs\n* T2DM\n* Willingness to check daily blood sugars\n* HbA1c between 53mmol(7%)- 108 mmol(12%)\n* Weight stable for 3 months\n* Capacity to consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Untreated thyroid dysfunction (patients who have been euthyroid on medication for at least 3 months can be included)\n* Use of medication adversely that affects diabetes control (e.g. steroids\u002F immunosuppressants\u002F certain antipsychotics)\n* Incapacity to give informed consent\n* History of an eating disorder\u002F purging behaviour\n* Previous gastric bypass\u002F banding\n* Use of Leptin Therapy\n* Untreated retinopathy","ALL","18 Years","99 Years",{"count":63,"type":64},20,"ESTIMATED","INTERVENTIONAL",[67],"NA","To evaluate the therapeutic efficacy and metabolic impact of a low energy diet (LED) in people with familial partial lipodystrophy and diabetes. Participants will be provided with a LED (total diet replacement) for 12 weeks, before the introduction of a stepped food transition. Metabolic effects will continue to be assessed for 1 year. In order to better understand why this intervention changes insulin sensitivity, we will also collect adipose and muscle tissue samples at baseline and 12 weeks into the intervention in participants willing to have these procedures performed. These samples will be used for histological, metabolite, gene expression and protein expression analyses.",[70,71,72],"Lipodystrophy","Diabetes","Diet Modification",[74,75,76,77,71],"Familial Partial Lipodystrophy","FPLD","Diet","Total Diet Replacement","2024-12-03",{"date":80,"type":81},"2024-12-05","ACTUAL",{"date":83,"type":81},"2020-01-16",{"date":85,"type":64},"2025-05",{"name":5,"class":6},1]