[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620932":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":35,"centralContacts":39,"locations":46,"responsibleParty":63,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":44,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":49,"whyStopped":44,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Edinburgh","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-Diabetic Group","EXPERIMENTAL","Participants without diabetes who are overweight or obese (BMI 30-45 kg\u002Fm²) will undergo an 8-12-week Total Diet Replacement (TDR) intervention (\\~800 kcal\u002Fday) followed by food reintroduction and weight maintenance. Includes metabolic testing, MRI scans, and blood sampling at baseline and follow-up.",[13],"Behavioral: Total Diet Replacement (TDR) Program",{"label":15,"type":10,"description":16,"interventionNames":17},"Pre-Diabetic Group","Participants with pre-diabetes who are overweight or obese (BMI 30-45 kg\u002Fm²) will receive the same TDR intervention and follow-up schedule as the Non-Diabetic Group, with additional oral glucose tolerance testing during screening.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Short-Duration Type 2 Diabetes Group","Participants with type 2 diabetes diagnosed \\\u003C6 years who are overweight or obese (BMI 30-45 kg\u002Fm²) will undergo the TDR intervention and extended follow-up (up to 12-24 months) with additional metabolic visits and blood sampling.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Long-Duration Type 2 Diabetes Group","Participants with type 2 diabetes diagnosed \\>10 years who are overweight or obese (BMI 30-45 kg\u002Fm²) will receive the same TDR intervention and standard follow-up schedule as other arms.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"BEHAVIORAL","Total Diet Replacement (TDR) Program","Participants will follow a structured Total Diet Replacement (TDR) program consisting of approximately 800 kcal\u002Fday using commercially available soups and shakes for 8-12 weeks. This is followed by a 2-week food reintroduction phase and a weight maintenance phase up to 6 months, supervised by a research dietitian. The intervention aims to induce rapid weight loss and assess its impact on intrapancreatic fat, insulin secretion, and type 2 diabetes remission. All participants receive dietary counseling and monitoring throughout the study.",[23,9,15,19],[33,34],"Low-Calorie Diet","Meal Replacement Program",[36],{"name":37,"affiliation":5,"role":38},"Ahmad Al-Mrabeh, PhD","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Study Team","CONTACT","+44(0)131 242 6717",null,"edrs@ed.ac.uk",[47],{"facility":48,"status":49,"city":50,"state":44,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Clinical Research Facility, Royal Infirmary of Edinburgh","RECRUITING","Edinburgh","EH16 4SA","United Kingdom","UK",{"type":55,"coordinates":56},"Point",[57,58],-3.19648,55.95206,{"lat":58,"lon":57},[61],{"name":41,"role":42,"phone":62,"phoneExt":44,"email":45},"+44 131 242 6717",{"type":64,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[66],{"name":67,"class":68},"NHS Lothian","OTHER_GOV","100620932","pancreas-lipotoxicity-in-t2d-edinburgh-diabetes-remission-study-edrs-100620932",false,"NCT07364045","Pancreas Lipotoxicity in T2D: Edinburgh Diabetes Remission Study (EDRS)","Mechanisms Mediating Reversible Lipotoxicity of the Pancreas in Obesity-induced Type 2 Diabetes: Edinburgh Diabetes Remission Study (EDRS)","EDRS","Inclusion Criteria:\n\n* Overweight\u002Fobese (BMI: 30-45 kg\u002Fm²) who have had T2D for less than 6 years or longer than 10 years, and are on treatment with diet alone or diet plus oral medication.\n* Overweight\u002Fobese (BMI: 30-45 kg\u002Fm²) who are at pre-diabetes stage, defined as fasting blood glucose 5.6-6.9 mmol\u002FL.\n* Overweight\u002Fobese (BMI: 30-45 kg\u002Fm²) who are non-diabetic (control group).\n* Age between 45 and 79 years inclusive.\n* Post-menopausal women only (to exclude sex hormone effects on lipid metabolism).\n* Good communication in English (able to give informed consent and follow dietary advice).\n* Willing and able to adhere to the study protocol, including dietary intervention and scheduled follow-up visits.\n\nExclusion Criteria:\n\n* Insulin therapy\n* HbA1c \\>12% (108 mmol\u002Fmol)\n* Weight loss \\>5 kg in last 6 months\n* Recent MI (within 6 months)\n* Known cancer in last 5 years\n* First-degree relatives of people with T2D (control group)\n* History of gestational diabetes\n* MRI contraindications (metal implants, claustrophobia)\n* Alcohol \\>14 units\u002Fweek\n* Advanced kidney or liver disease\n* Use of steroids or antipsychotics\n* Participation in another clinical trial\n* Life expectancy \\\u003C1 year\n* Allergy to local anaesthetic (for biopsy subgroup)\n* Any disorder that may jeopardise safety or compliance",true,"ALL","45 Years","79 Years",{"count":82,"type":83},104,"ESTIMATED","INTERVENTIONAL",[86],"NA","This study aims to investigate how fat accumulation in the pancreas contributes to the development of type 2 diabetes (T2D), and how weight loss may reverse this process. Previous research has shown that reducing body weight can lead to diabetes remission, and this was accompanied by lowering intrapancreatic fat and restoration of insulin secretion, but the mechanisms behind this are not fully understood. In particular, the study aims to unravel the role of hepatic de novo lipogenesis (DNL) and lipoprotein metabolism on pancreas lipotoxicity and beta cell recovery after weight loss.\n\nFour groups of participants will be recruited (n=26 per group): non-diabetic, pre-diabetic, short-duration T2D (\\\u003C6 years), and long-duration T2D (\\>10 years). Participants will be aged between 45 and 79 years and have a BMI between 30 and 45 kg\u002Fm². All participants will follow a structured weight loss programme using an 800 kcal\u002Fday Total Diet Replacement (TDR) for 8-12 weeks, followed by dietary support to maintain weight loss. The study is sponsored by NHS-Lothian and the University of Edinburgh and will be carried out at the Clinical Research Facility, Royal infirmary of Edinburgh by a specialist team (Senior Diabetes Research Nurse, Clinical Fellow, and Research Dietitian).\n\nThe primary endpoint of this study is to achieve a 10-15% reduction in body weight (\\~10 kg) through a low-calorie diet (800 kcal\u002Fday) to induce T2D remission and maintain this weight loss with structured dietary support for up to 6-12 months. The primary aim is to compare hepatic de novo lipogenesis-the conversion of sugar into fat by the liver-and lipoprotein export among the groups, and to examine how these parameters change in response to weight loss, improvement in metabolic status, and restoration of normal pancreatic function.\n\nSecondary endpoints include changes in weight, HbA1c, intraorgan fat (liver\u002Fpancreas), pancreas volume and tissue characteristics, beta cell mass and function (MRI\u002Fmixed meal test), circulating blood markers (i.e. lipids, exosomes, adipokines, and inflammatory markers), and the change in adipose tissue biology (fat biopsies).\n\nUltimately, this study aims to understand the mechanisms of T2D remission. It will help clarify the sequence of metabolic events leading to reversible pancreatic lipotoxicity and may inform the development of new, targeted therapies for T2D.",[89],"Type 2 Diabetes",[89,91,92,93],"Obesity","Remission","Weight loss","2026-06-17",{"date":96,"type":97},"2026-06-18","ACTUAL",{"date":99,"type":97},"2026-06-15",{"date":101,"type":83},"2029-12-31",{"name":5,"class":6},1]