[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lipodystrophy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lipodystrophy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,52,65,89,114,136,169,197],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100054144","phase-2-effects-of-meal-macronutrients-on-postprandial-lipids-100054144",false,"NCT07313787","Effects of Meal Macronutrients on Postprandial Lipids","Prospective Cross-Over Study of the Effects of Meal Macronutrients on Postprandial Lipids","* INCLUSION CRITERIA:\n\nCommon inclusion criteria (all groups):\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age \\>= 18 years\n2. Average alcohol intake in the past 6 months \\\u003C 3 drinks (approximately 30g) per day (male) or \\\u003C 2 drinks (approximately 20 g) per day (female)\n\nHealthy control specific inclusion criteria:\n\n1. In good general health with no known active medical conditions as evidenced by medical history\n2. Fasting glucose \\\u003C100 mg\u002FdL\n3. HbA1c \\\u003C5.7%\n4. Fasting triglycerides \\\u003C150 mg\u002FdL\n5. ALT and AST within normal limits\n6. BMI \\>=18.5 to \\\u003C25 kg\u002Fm\\^2 (or \\\u003C23 kg\u002Fm\\^2 in participants of Asian descent)\n7. Not taking any medications or supplements that, in the opinion of the investigator, would interfere with interpretation of study data.\n\nMetabolic syndrome specific inclusion criteria\n\n1\\. Obesity defined as either\n\n1. BMI \\>30 kg\u002Fm\\^2 (or \\>=27 kg\u002Fm\\^2 in participants of Asian descent), OR\n2. Elevated waist circumference as defined below:\n\n   * Country\u002FEthnic group - Europid, Sub-Saharan African, Eastern Mediterranean and Middle East (Arab):\n\n     --Sex: Male - Waist circumference: \\>=94cm\n\n     --Sex: Female - Waist circumference: \\>=80cm\n   * Country\u002FEthnic group - South Asian, Chinese, Japanese, Ethnic South and Central American:\n\n     * Sex: Male - Waist circumference: \\>=90cm\n     * Sex: Female - Waist circumference: \\>=80cm\n\n       2\\. Elevated triglycerides defined as EITHER\n\n       2a. Fasting triglycerides \\>= 150 mg\u002FdL at screening, OR\n\n       2b. Specific treatment for hypertriglyceridemia\n\n       3\\. Low HDL cholesterol, defined as EITHER\n\n       3a. HDL \\\u003C40 mg\u002FdL (males) or \\\u003C50 mg\u002FdL (females) at screening, OR\n\n       3b. Specific treatment for low HDL\n\n       4\\. Elevated blood pressure defined as EITHER\n\n       4a. Systolic BP \\>= 130 at screening, OR\n\n       4b. Diastolic BP \\>= 85 mm Hg at screening, OR\n\n       4c. Treatment of previously diagnosed hypertension\n\n       5\\. Elevated glucose defined as EITHER\n\n       5a. HbA1c \\>= 5.7% (at screening), OR\n\n       5b. Fasting serum glucose \\>= 100 mg\u002FdL (at screening), OR\n\n       5c. 2-hour post-load glucose levels \\>= 140 mg\u002FdL (by history), OR\n\n       5d. Prior diagnosis of type 2 diabetes\n\n   Lipodystrophy-specific inclusion criteria:\n   1. Clinical diagnosis of generalized or partial lipodystrophy based on reduction in adipose tissue outside the normal range in some or all adipose depots (including, at aminimum, the gluteofemoral depot).\n   2. Insulin resistance as defined by fasting insulin \\>22.5 or high exogenous insulin requirement (\\> 2 units per kg per day or \\> 200 units total per day) at screening.\n\n   Nephrotic syndrome specific inclusion criteria\n   1. History of biopsy proven non-diabetic glomerular disease (any histology)\n   2. Nephrotic range proteinuria defined by ANY of the following:\n\n   2a. Protein\u002Fcreatinine ratio uPCR \\>= 3.5 g\u002Fg at screening, OR\n\n   2b. 24 hour protein excretion \\>= 3.5 gr\u002F24hr) at screening, OR\n\n   2c. History of nephrotic range proteinuria (as defined above) within the past 5 years but in complete (defined as proteinuria \\\u003C= 0.3 g\u002Fday or partial remission (defined as a 50% or greater decrease in proteinuria compared to baseline and proteinuria \\\u003C 3.5 g\u002Fday) based on 24 hr urine or uPCR at time of screening\n\n   EXCLUSION CRITERIA:\n\n   Common exclusion criteria (all groups):\n\n   An individual who meets any of the following criteria will be excluded from participation in this study:\n   1. Consuming extreme macronutrient diet (e.g., very low-carbohydrate, high fat diets such as ketogenic, paleo or Atkins diets, among others).\n   2. Plans to actively gain or lose weight during the study period (other than changes in water balance as clinically needed in subjects with nephrotic syndrome).\n   3. Change in body weight of \\>5% or \\>3 kg (whichever is larger) in the 3 months prior to screening (by participant report) in participants who do NOT have nephrotic syndrome.\n   4. Body weight \\>450 lbs (upper limit that can be accommodated by DXA scanner).\n   5. Participating in a regular strenuous exercise program (\\> 2h\u002Fweek of vigorous activity) as determined by volunteer report or evidence of vigorous exercising in order to lose weight, change body shape, or to counteract the effects of eating.\n   6. Uncontrolled diabetes, defined as HbA1c \\>9% at screening.\n   7. Lipemia defined as fasting or non-fasting triglycerides of \\>1000 mg\u002FdL at screening.\n   8. Renal dysfunction defined as eGFR \\\u003C50 mL\u002Fmin\u002F1.73 m\\^2 at screening.\n   9. In participants with liver disease, history of decompensated advanced liver disease, defined as direct bilirubin \\> 0.5 g\u002FdL, PT \\> 18 seconds, albumin \\\u003C 3 g\u002FdL, MELD score \\> 12, or history of ascites, encephalopathy, variceal bleeding, spontaneous bacterial\n\n      peritonitis or liver transplant.\n   10. History of hypertriglyceridemia-induced pancreatitis within 3 months prior to screening.\n   11. Positive pregnancy test or breastfeeding at screening.\n   12. Clinically significant abnormalities in thyroid function, blood counts, as assessed by screening labs.\n   13. Acute cardiovascular events within the past 6 months\n   14. Anemia (Hgb \\\u003C10 mg\u002FdL in women or \\\u003C12 mg\u002FdL in men) at screening\n   15. Food allergies or other dietary restrictions that could increase risk associated with test meals or cause the subject to be unwilling to consume test meals (i.e. celiac disease, vegan diets).\n   16. Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption.\n   17. Subjects treated with tamoxifen, estrogens, or progestins that have not been stable for \\>4 weeks prior to screening.\n   18. Blood donation in the last 2 weeks or planned blood donation during the study\n   19. Subjects requiring regular transfusions for any reason.\n   20. Subjects with known gastroparesis\n   21. Inability to adhere to Lifestyle Considerations throughout study duration.\n   22. Inability of the subject to understand and the unwillingness to sign a written informed consent document.\n   23. Unwillingness to comply with all study procedures and unavailable for the duration of the study\n   24. Any other condition or medication which, in the opinion of the investigator, increases risk to the subject, prevents the subject from complying with study procedures, prevents the subject from completing the study, or interferes with the interpretation of study results.","ALL","18 Years","120 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background:\n\nAbnormal fats in the blood can lead to many problems, including heart disease. Researchers want to learn more about how eating meals with different levels of nutrients affects fats in the blood. Specifically, they want to study people with too much body fat, too little body fat, and a kidney problem called nephrotic syndrome.\n\nObjective:\n\nTo learn more about how different types of foods affect fat levels in the blood.\n\nEligibility:\n\nPeople aged 18 years or older with a health condition that affects how their body handles fats. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have 2 overnight stays in the clinic within 6 months. At each visit, after staying overnight, they will eat a breakfast casserole. At 1 visit, breakfast will be a high-fat, low carbohydrate meal. At the other, it will be a high-carbohydrate, low-fat meal.\n\nParticipants will have a tube inserted into a vein in their arm. They will have blood drawn via the tube 12 times in 8 hours: 2 times before they eat the breakfast and 10 times after.\n\nParticipants will have other tests during their stays:\n\n* A resting metabolic test captures the air they exhale and measures how much energy they use at rest.\n* A dual energy X-ray absorptiometry (DXA) scan measures how much fat and muscle they have.\n* A Fibroscan is a special type of ultrasound of the liver.\n* A body surface scan uses lasers to measure the total area of the body.\n* A bioelectric impedance (BIS) exam measures how fast small electric currents move through their body.\n\nParticipants may opt to have a third visit. At this visit, the breakfast will be high in protein....",[27,28,29,30,31,32],"Nephrotic Syndrome","Lipodystrophy","Metabolic Syndrome","Healthy Volunteer","Diabetes","Metabolic Associated Steatotic Liver Disease",[34,35,36,37,38],"postprandial lipids","macronutrient","CARBOHYDRATES","FATS","Proteins","NOT_YET_RECRUITING","2026-07-10",{"date":42,"type":43},"2026-07-13","ACTUAL",{"date":45,"type":21},"2026-07-16",{"date":47,"type":21},"2031-08-01",{"name":49,"class":50},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":53,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":25,"conditions":56,"keywords":57,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":64,"locationsCount":51},"100617066",{"count":20,"type":21},[24],[27,28,29,30,31,32],[34,35,36,37,38],"2026-07-01",{"date":60,"type":43},"2026-07-02",{"date":62,"type":21},"2026-07-07",{"date":47,"type":21},{"name":49,"class":50},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":75,"phases":4,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":51},"100515824","feasibility-of-adipose-tissue-triglyceride-tg-labelling-in-familial-partial-lipodystrophy-fpld-100515824","NCT05996536","Feasibility of Adipose Tissue Triglyceride (TG) Labelling in Familial Partial Lipodystrophy (FPLD)","A Pilot Study to Assess Feasibility of Adipose Tissue Triglyceride (TG) Labelling in Familial Partial Lipodystrophy (FPLD)","* INCLUSION CRITERIA:\n\nCommon inclusion criteria (FPLD and Controls):\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Age \\>= 18 and \\\u003C= 65 years\n3. Agreement to adhere to Lifestyle Considerations throughout study duration.\n4. Weight stability (per the subject) within approximately 3 kg in the 3 months prior to screening, with no plans to actively gain or lose weight during the study period.\n\nFPLD-specific inclusion criteria:\n\n1. Clinical diagnosis of partial lipodystrophy based on reduction in adipose tissue outside the normal range in selected adipose depots (including, at a minimum, the gluteofemoral depot) with preservation of adipose tissue in other depots.\n2. Adequate abdominal and thigh adipose tissue for feasible subcutaneous fat biopsy, as judged by the investigator.\n\nCONTROL MATCHING CRITERIA:\n\nWhen possible, control subjects will be individuals matched 1:1 with the FPLD subjects based on the following criteria (in order of priority). These criteria will be considered when assessing eligibility but are not strict inclusion criteria.\n\n1. Sex\n2. Age plus-minus 5 years\n3. Diabetic status\n4. Abdominal circumference plus-minus 10 cm\n5. Height plus-minus 5 cm\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Uncontrolled diabetes, defined as HbA1C \\>8% at screening.\n2. Use of insulin secretagogues (sulfonylureas) in week prior to Study Visit 1.\n3. Changes in insulin dose \\>30% of total daily dose in the 2 weeks prior to Study Visit 1.\n4. Use of niacin in the week prior to Study Visit 1.\n5. Use of antiplatelets that cannot be safely held for the appropriate duration prior to each biopsy visit, including Plavix (one week prior to biopsy), aspirin (one week prior to biopsy) and NSAIDS (48 hours prior to biopsy).\n6. Chronic use of anticoagulant medications that cannot be safely stopped for an appropriate duration of time prior to a biopsy procedure.\n7. Lipemia defined as non-fasting triglycerides of \\>1000 mg\u002FdL at screening.\n8. Renal dysfunction defined as GFR \\\u003C60 mL\u002Fmin\u002F1.73 m\\^2 at screening.\n9. Consuming extreme macronutrient diet (e.g., very low-carbohydrate, high fat diets such as ketogenic, paleo or Atkins diets, among others).\n10. Positive pregnancy test or breastfeeding at screening.\n11. History of HIV, hepatitis B or C infection.\n12. History of acquired lipodystrophy.\n13. Clinically significant abnormalities in thyroid function, liver function, blood counts, or blood minerals as assessed by screening labs.\n14. Inability to comply with planned study procedures.\n15. Inability of subject to understand and the willingness to sign a written informed consent document.\n16. Any condition which in the opinion of the investigator increases risk to subjects, prevents subject from complying with study procedures, prevents the subject from completing the study, or interferes with the interpretation of study results.","65 Years",{"count":74,"type":21},14,"OBSERVATIONAL","Background:\n\nPeople with familial partial lipodystrophy (FPLD) do not store fat in the body normally. This can lead to serious illnesses such as diabetes and heart disease. To learn more about FPLD, researchers want to compare the fat tissue in people with this disease to the fat tissue of healthy people.\n\nObjective:\n\nTo collect and analyze samples of fat tissue in people with and without FPLD.\n\nEligibility:\n\nPeople aged 18 to 65 years with FPLD. Healthy adults are also needed.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam. The size and shape of their body will be measured. They will have an imaging scan to measure their bones, muscle, and fat.\n\nParticipants will be given heavy water to drink at home. The water contains a tracer to help measure the fat in their blood. They will drink 1 vial 3 times a day.\n\nAfter drinking the water for 9 days, participants will come to the clinic for a 3-day stay. They will eat only foods provided by the hospital; the foods will contain tracers. A needle will be inserted into a vein in the arm; participants will receive infusions of other tracers through this needle into their blood; this needle will also be used to draw blood samples for testing.\n\nOn their third day in the clinic, participants will have biopsies: Small samples of fat will be removed from under the skin on the belly and thigh.\n\nParticipants may return for a follow-up visit 8 days after leaving the clinic. Blood draws and fat tissue biopsies will be repeated.",[28],[28,79],"Adipose Tissue","RECRUITING","2026-06-13",{"date":83,"type":43},"2026-06-16",{"date":85,"type":43},"2024-01-03",{"date":87,"type":21},"2027-06-01",{"name":49,"class":50},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":75,"phases":4,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":51},"100471450","natural-history-of-pregnancy-and-pregnancy-outcomes-in-metreleptin-treated-vs-untreated-subjects-with-lipodystrophy-100471450","NCT05419037","Natural History of Pregnancy and Pregnancy Outcomes in Metreleptin-Treated vs Untreated Subjects With Lipodystrophy","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Women with lipodystrophy who had pregnancies with or without use of metreleptin:\n\n  * Female, aged \\>= 18 years\n  * Clinical diagnosis of non-HIV associated generalized or partial lipodystrophy\n  * History of one or more pregnancies\n* Offspring of women with lipodystrophy who had pregnancies while taking metreleptin:\n\n  * Males or females aged \\>=1 month\n  * Mothers took metreleptin during their pregnancy\n  * Availability of a biobanked blood specimen or willingness to provide a blood specimen\n\nNote that subjects treated with metreleptin during pregnancy may participate in this study regardless of the participation of their offspring.\n\nEXCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must not meet any of the following criteria:\n\n* Inability of subject or guardian to understand or the unwillingness to sign a written informed consent document (except as noted below with \\*)\n* Pregnancy.\n\n  * Subjects who otherwise meet inclusion\u002Fexclusion criteria but who are not reachable to obtain informed consent may be included under a waiver of consent.","6 Months","98 Years",{"count":98,"type":21},90,"Background:\n\nLipodystrophy is a health problem in which the body does not have enough fat tissue. People with lipodystrophy may not make enough of the hormone leptin. Leptin regulates hunger. Low leptin levels trigger hunger. People with lipodystrophy can have many health problems. They may take a drug (metreleptin) that mimics leptin. Little is known about how taking metreleptin may affect a pregnancy. Metreleptin may be helpful or harmful to pregnant women. It may also affect the health of the child who is born.\n\nObjective:\n\nThis natural history study will collect data about the effects of taking metreleptin while pregnant.\n\nEligibility:\n\nWomen aged 18 years or older with lipodystrophy who have been pregnant. Women who did and who did not take metreleptin during their pregnancies are needed. Children of women with lipodystrophy who took this drug during pregnancy are also needed.\n\nDesign:\n\nParticipants will have 1 study visit. This visit may be by phone, by telehealth, or in-person.\n\nParticipants will answer questions about their pregnancies.\n\nThey will discuss any health problems they had.\n\nThey will be asked about any medicines they took before and during their pregnancies.\n\nThey will be asked about the health of their children.\n\nParticipants medical records will be reviewed.\n\nParticipants may need to provide a blood sample. They may also be asked to provide a sample of breastmilk.\n\nParticipants children may also be asked to provide a blood sample....",[28],[102,103,104,105],"Metreleptin","Pregnancy","Off-Spring","Natural History","2026-06-12",{"date":108,"type":43},"2026-06-15",{"date":110,"type":43},"2022-09-07",{"date":112,"type":21},"2029-03-01",{"name":49,"class":50},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":133,"locationsCount":4},"100417005","expanded-access-to-regn4461-for-patients-with-diseases-associated-with-deficient-leptin-signaling-100417005","NCT04710056","Expanded Access to REGN4461 for Patients With Diseases Associated With Deficient Leptin Signaling","Key Inclusion: N\u002FA\n\nKey Exclusion: N\u002FA","EXPANDED_ACCESS","Provide Expanded Access to REGN4461 for patients with diseases associated with deficient leptin signaling.",[28,123,124],"Generalized Lipodystrophy (GLD)","Monogenic Obesity (MOB)",[126,127,128],"Leptin (LEP)","Leptin Receptors (LEPR)","Biallelic Loss of Function Variants of the LEP Gene","AVAILABLE","2026-03-10",{"date":132,"type":43},"2026-03-12",{"name":134,"class":135},"Regeneron Pharmaceuticals","INDUSTRY",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":147,"conditions":148,"keywords":153,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":168},"100534292","susceptibility-to-infectious-diseases-in-obesity-an-endocrine-translational-sociologic-evaluation-siderale-100534292","NCT06236932","Susceptibility to Infectious Diseases in obEsity: an endocRine trAnslational socioLogic Evaluation, \"SIDERALE\"","PRIN \"SIDERALE\": Susceptibility to Infectious Diseases in obEsity: an endocRine trAnslational socioLogic Evaluation","SIDERALE2020","Inclusion Criteria:\n\n* essential obesity (BMI : 30-35 Kg\u002Fm2)\n* genetic forms of obesity (BMI: 30-35 Kg\u002Fm2)\n* obesity (BMI:30-35 Kg\u002Fm2) associated with T2DM\n* obesity (BMI:30-35 Kg\u002Fm2) associated with endocrinopathies\n* lipodystrophy\n\nExclusion Criteria:\n\n* pregnancy, breast-feeding, alcohol and drug abuse, known severe haematological, cardiac, liver, kidney, mental diseases, hypogonadisms, hormonal treatments including estroprogestins, intolerance to melatonin or excipients",{"count":20,"type":21},[146],"NA","Obesity is a life-threatening disease, defined by excessive fat accumulation that increases the risk of other diseases such as cardiovascular events, hypertension, diabetes and cancer. Obesity is also a risk factor for nosocomial infections and is associated with worse COVID-19 outcomes, although anthropometric measurements are not routinely recorded during hospitalization and lack of a registry data does not allow performing retrospective studies.Obesity is closely related to chronodisruption, characterized by deregulation of physiological and behavioral central and peripheral circadian rhythms contributing to the obesity-related metabolic impairment. Eating and sleeping time schedules are relevant synchronizers of humans' biological clock. Several studies suggest a role of dietary interventions in rewiring the circadian rhythm, with Mediterranean diet (MD) regulating nutritional patterns. Moreover, considering its positive impact on sleep quality, melatonin intake was suggested as a potential regulator of circadian rhythms. The relation between chronodisruption, obesity and infections has not been investigated, and a first proof of concept (Pilot study) will aim at investigating it. Three cohorts of obese patients with different aetiology (essential obesity, obesity with type 2 diabetes, genetic forms of obesity) and a cohort of lipodystrophic patients will be enrolled in the study, which is designed as a two-phases protocol. During the first phase (0-12 weeks (w)) patients will be subjected to dietary intervention with hypocaloric MD; in a second phase (12-24w), melatonin 1mg\u002Fdie before sleep will be added to the hypocaloric MD. The susceptibility to infections will be investigated through the evaluation of 1) the number of events - i.e. flu- or flulike syndromes, skin, respiratory, digestive, urinary infections-per patient of the 4 groups and the blood assays to detect the infection with Epstein-Barr, Cytomegalovirus, Varicella, Measles and SARS-CoV-2 IgG and IgM; hepatitis C and hepatitis B core antibodies and Quantiferon TB Gold, 2) the clock genes rhythm and TLRs expression in patient immune cells at baseline, 12w and 24w.The mutual relationship between biomedical values, environmental and social conditions, and lifestyle habits will be evaluated by structured questionnaires. Validation of questionnaires to explore the susceptibility to infections is another delivery planned for the current study.",[149,150,28,151,152],"Obesity","Type2diabetes","Infections","Obesity Associated Disorder",[149,151,154,155,156,157],"Melatonin","Mediterranean Diet","Gut microbiota","Chronobiology","2025-08-07",{"date":160,"type":43},"2025-08-12",{"date":162,"type":43},"2023-12-29",{"date":164,"type":21},"2026-10-29",{"name":166,"class":167},"Federico II University","OTHER",4,{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":51},"100354850","low-energy-diet-and-familial-partial-lipodystrophy-100354850","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","99 Years",{"count":178,"type":21},20,[146],"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.",[28,31,182],"Diet Modification",[184,185,186,187,31],"Familial Partial Lipodystrophy","FPLD","Diet","Total Diet Replacement","2024-12-03",{"date":190,"type":43},"2024-12-05",{"date":192,"type":43},"2020-01-16",{"date":194,"type":21},"2025-05",{"name":196,"class":167},"Cambridge University Hospitals NHS Foundation Trust",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":51},"100499899","assess-the-possibility-of-diagnosing-diabetes-and-rediabetes-following-oral-induced-hyperglycemia-in-patients-with-dunnigans-partial-familial-lipodystrophy-by-replacing-75-g-of-glucose-with-a-standardized-carbohydrate-breakfast-and-continuous-interstitial-monitoring-glucose-100499899","NCT05789251","Assess the Possibility of Diagnosing Diabetes and Rediabetes Following Oral Induced Hyperglycemia in Patients With Dunnigan's Partial Familial Lipodystrophy by Replacing 75 g of Glucose With a Standardized Carbohydrate Breakfast and Continuous Interstitial Monitoring Glucose)","HGPO-DUN","Inclusion Criteria:\n\n* Subject with Dunnigan's partial familial lipodystrophy followed at Reunion University Hospital not known to be diabetic.\n\nAged 18 to 75 Having given their informed consent.\n\nExclusion Criteria:\n\n* Diabetic patient Patient scheduled for scan within 7 days of freestyle placement protected persons: \"pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, minor, and person subject to a measure of legal protection: guardianship or curatorship)\"",{"count":205,"type":21},60,[146],"Dunnigan's syndrome is a partial familial lipodystrophy due to a mutation in the Lamine A LMNA gene. This very rare syndrome is 20 times more common in Réunion compared to the rest of Europe with several families suffering from a unique variant of LMNA, the p.(Thr655Asnfs\\*49) variant known as the \"Reunion variant\", the appearance of which in Reunion dates back to the 17th century. This variant is expressed in homozygous and heterozygous form and has only been identified in subjects from Reunion. Clinically, patients with Dunnigan's have an absence of subcutaneous fatty tissue which mainly affects the lower part of the body and leads to severe insulin resistance responsible for early diabetes. To detect these metabolic complications as early as possible, an annual follow-up of the subjects is recommended with the performance of an OGTT test annually in non-diabetic subjects. This problem is identical for patients with cystic fibrosis leading to the same recommendation. However, whether in our experience of monitoring patients with Dunningan's lipodystrophy, in subjects at risk of diabetes or in subjects with cystic fibrosis, the OGTT test and even more so its repetition is poorly accepted, which can lead to lack of patient follow-up. An alternative solution to the OGTT is therefore justified.\n\nIn the literature, different avenues have been explored. First, given oral glucose intolerance, replacement with a standardized breakfast has been explored in several studies. Another alternative tested in the population of subjects with cystic fibrosis is the use of an interstitial glucose sensor for screening for carbohydrate abnormalities.\n\nIn view of the literature, we formulate several hypotheses that will be tested in our study:\n\n1. The intake of a standardized breakfast containing 75g of carbohydrates is comparable to the ingestion of 75g of glucose on the result of the OGTT test at 120 min for the diagnosis of carbohydrate abnormalities (diabetes and prediabetes) in patients with Dunnigan's lipodystrophy.\n2. The continuous recording of interstitial glycaemia over several days allows the diagnosis of glucidic abnormalities equivalent to the classic OGTT in this population; possibly by identifying glycemic variations not seen by a single OGTT test. Thus the installation of an interstitial sensor over several days could be an alternative to the realization of the OGTT in the identification of carbohydrate disorders in patients with Dunnigan's lipodystrophy.\n3. There will be a similar profile but a time lag between venous glycemic curves and interstitial blood glucose measurements after OGTT.\n4. Replacing the oral glucose load of the classic OGTT (gold standard) with a standardized carbohydrate breakfast leads to similar interstitial glycaemia curves but with a time lag.",[28],"2024-08-20",{"date":211,"type":43},"2024-08-21",{"date":213,"type":43},"2023-06-19",{"date":215,"type":21},"2025-06-30",{"name":217,"class":167},"Centre Hospitalier Universitaire de la Réunion"]