[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532342":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":36,"responsibleParty":58,"collaborators":61,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":18,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Very-low calorie diet","EXPERIMENTAL","Two weeks of \\~800kcal\u002Fday",[13],"Behavioral: Very-low calorie diet",{"label":15,"type":16,"description":17,"interventionNames":18},"Free-living control","NO_INTERVENTION","No intervention control group",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","\\~800 kcal\u002Fday delivered via commercially available diet plan (NUPO).",[9],[25],"VLCD",[27],{"name":28,"affiliation":29,"role":30},"Cody G Durrer, Ph.D.","Center for Aktiv Sundhed - Rigshospitalet","PRINCIPAL_INVESTIGATOR",[32],{"name":28,"role":33,"phone":34,"phoneExt":18,"email":35},"CONTACT","+4550104538","cody.garett.durrer@regionh.dk",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Rigshospitalet - CFAS","RECRUITING","Copenhagen","Capital Region","2100","Denmark","DK",{"type":46,"coordinates":47},"Point",[48,49],12.56553,55.67594,{"lat":49,"lon":48},[52,56],{"name":53,"role":33,"phone":54,"phoneExt":18,"email":55},"Inge Holm","+4535457621","inge.holm@regionh.dk",{"name":57,"role":30,"phone":18,"phoneExt":18,"email":18},"Cody G Durrer, PhD",{"type":30,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Cody Garett Durrer","PhD. Post doc",[62,64,67],{"name":63,"class":6},"Diabetesforeningen",{"name":65,"class":66},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":68,"class":69},"Region Hovedstadens Forskningsfond","UNKNOWN","100532342","depletion-of-liver-fat-in-type-2-diabetes-100532342",false,"NCT06211556","Depletion of Liver Fat in Type 2 Diabetes","A Parallel Group Randomized Trial Investigating the Effect of Hepatic Fat Depletion Via a Very-low Calorie Diet on Hepatokine Secretion and Function in People With Type 2 Diabetes","DepLiv","Inclusion Criteria:\n\n* Men and women 30-70 years of age\n* The target population is persons with type 2 diabetes. I.e., persons are eligible if they are diagnosed with type 2 diabetes either only with metformin for managing glucose or without use of glucose lowering medications. Persons with a HbA1c ≥ 48 mmol\u002Fmol with or without the use of glucose lowering medications are also eligible. Any glucose lowering medications other than metformin are disallowed (described under \"Exclusion criteria, below)\n* Diabetes duration \\\u003C 7 years\n* Body Mass Index (BMI) ≥ 30 kg\u002Fm2 and ≤ 40 kg\u002Fm2\n* Accepts medical regulation by the study endocrinologist\n* Inactivity, defined as \\\u003C 1,5 hours of structured physical activity pr. week at moderate intensity and cycling \\\u003C 30 minutes\u002F5 km pr. day at moderate intensity (moderate intensity = out of breath but able to speak)\n\nExclusion Criteria:\n\n* HbA1c ≥ 75 mmol\u002Fmol with no glucose lowering medications\n* HbA1c ≥ 64 mmol\u002Fmol with mono glucose lowering therapy (if compliant with the prescription)\n* HbA1c ≥ 57 mmol\u002Fmol with ≥ dual glucose lowering therapy (if compliant with the prescription)\n* Diagnosis of Type 1 diabetes, MODY-diabetes, Type 1½ diabetes or LADA-diabetes\n* eGFR\\\u003C60mL\u002Fmin (assessed via screening blood sample)\n* Treatment with any glucose-lowering medications other than metformin (e.g., insulin (long and\u002For short acting), sulphonylurea based drugs, glucagon-like peptide 1 receptor agonists, dipeptidyl peptidase 4 inhibitors, sodium-glucose co-transporter-2 inhibitors, thiazolidinediones, alpha-glucosidase inhibitors)\n* Presence of metal in the body that would contraindicate an MRI scan\n* Known or signs of intermediate or severe microvascular complications to diabetes (retino-, neuro- or nephropathy)\n* Known cancer\n* Lung disease, other than asthma that can be managed with beta2-agonists and does not exhibit seasonal variation\n* Known cardiovascular disease\n* Known hyperthyroid disease\n* Clinical or biochemical signs of hypothyroid disease\n* Changes in hypothyroid disease treatment within the last 3 three months prior to enrolment\n* Known liver disease - defined as ALAT or ASAT elevated three times above upper limit\n* Known autoimmune disease\n* Psoriasis disease requiring systemic treatment or cutan elements bigger than a total area of 25 cm2\n* Other endocrine disorder causing obesity\n* Current treatment with anti-obesity medication\n* Current treatment with anti-inflammatory medication\n* Weight loss of \\> 5kg within the last 6 months\n* Changes in symptoms or anti-depressive medication three months prior to enrolment\n* Diagnosis of psychiatric disorder or treatment with anti-psychotic medication\n* History of suicidal behavior or ideations within the last three months prior enrolment\n* Previous surgical treatment for obesity (excluding liposuction \\> 1 year prior to enrolment)\n* Pregnant\u002Fconsidering pregnancy, or lactating\n* Functional impairments that prevent the performance of intensive exercise\n* Participation in other research intervention studies\n* Macroalbuminuria at pre-screening (assessed via screening blood sample)\n* Biochemical sign of other major diseases\n* Presence of circulating glutamatdecarboxylase anti body (GAD) 65 (assessed via screening blood sample)\n* Objective findings that contraindicate participation in intensive exercise\n* Incidental findings that contraindicate participation in the study\n* Unable to allocate the needed time to fulfill the intervention\n* Language barrier, mental incapacity, unwillingness, or inability to understand and be able to complete the interventions","ALL","30 Years","70 Years",{"count":82,"type":83},42,"ESTIMATED","INTERVENTIONAL",[86],"NA","The aim of this randomized trial is to determine whether liver fat depletion via a short-term (i.e., two weeks) very-low calorie diet will restore the normal exercise-induced secretion of a signaling protein (fibroblast growth factor 21) from the liver in people living with type 2 diabetes. Participants will have their liver fat, body composition, and various markers of metabolic health assessed and then will be randomized to either the very-low calorie diet intervention or a free-living control group for two weeks. Upon completion of the two-week intervention period, participants will redo all of the pre-intervention assessments. The changes in the assessments from before vs. after the intervention period will be compared between the two intervention groups (i.e., the very-low calorie diet group vs. the free living control group).",[89,90],"Type2diabetes","Obesity",[25,92,93,94,95,96],"Exercise","Type 2 diabetes","hepatokines","Hepatic steatosis","Liver fat","2025-07-17",{"date":99,"type":100},"2025-07-22","ACTUAL",{"date":102,"type":100},"2024-02-01",{"date":104,"type":83},"2026-03",{"name":5,"class":6},1]