[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649235":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":90,"collaborators":93,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":18,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"General University Hospital, Prague","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Caloric Restriction Group","EXPERIMENTAL","Obese non-diabetic premenopausal women and age-eligible men will undergo an eight-week very-low-calorie formula diet followed by a weight-maintenance phase. Participants will receive nutritional counseling and undergo longitudinal clinical, anthropometric, biochemical, imaging, and cellular assessments to evaluate changes in vertebral bone marrow adipose tissue, bone mineral density, body composition, metabolic parameters, and the phenotype of bone marrow- and adipose tissue-derived mesenchymal stromal cells.",[13],"Behavioral: Caloric Restriction",{"label":15,"type":16,"description":17,"interventionNames":18},"Lean Healthy Baseline Reference Group","NO_INTERVENTION","Lean healthy premenopausal women or age-eligible men will serve as a baseline reference group. Participants in this arm will not receive caloric restriction or any other study intervention and will not undergo longitudinal follow-up. Baseline assessments include clinical and anthropometric evaluation, blood sampling, bone mineral density and body composition measurements, magnetic resonance imaging and proton magnetic resonance spectroscopy of the lumbar spine, and collection of bone marrow and subcutaneous adipose tissue samples. Their baseline findings will be compared with those of participants with obesity.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Caloric Restriction","Participants will follow a formula-based very-low-calorie diet (Cambridge Weight Plan) providing approximately 600-800 kcal per day (2.5-3.35 MJ per day) for 8 weeks. This will be followed by a 4-month low-calorie diet phase and subsequently by a weight-maintenance phase. Participants will receive nutritional counselling, and dietary adherence, body weight, physical activity, and clinical status will be monitored during scheduled study visits.",[9],[26],{"name":27,"affiliation":28,"role":29},"Michaela Tencerova, MSc, PhD","Institute of Physiology of the Czech Academy of Sciences","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Vit Zikan, MD, Ph.D.","CONTACT","+420731670425","vit.zikan@vfn.cz",{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},"Michaela Tencerova, M.Sc., Ph.D.","+420 241 062737","michaela.tencerova@fgu.cas.cz",[41,67,80],{"facility":42,"status":43,"city":44,"state":18,"zip":45,"country":46,"countryCode":18,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"General University Hospital in Prague","RECRUITING","Prague","12800","Czechia",{"type":48,"coordinates":49},"Point",[50,51],14.42076,50.08804,{"lat":51,"lon":50},[54,58,60,61,63,65],{"name":55,"role":33,"phone":56,"phoneExt":18,"email":57},"Ivan Raska, MD, Ph.D.","+420224969280","ivan.raska@vfn.cz",{"name":32,"role":33,"phone":59,"phoneExt":18,"email":35},"+420224969285",{"name":32,"role":29,"phone":18,"phoneExt":18,"email":18},{"name":55,"role":62,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"name":64,"role":62,"phone":18,"phoneExt":18,"email":18},"Martin Matoulek, MD, Ph.D.",{"name":66,"role":62,"phone":18,"phoneExt":18,"email":18},"Aleš Paclík, MD",{"facility":68,"status":43,"city":44,"state":18,"zip":45,"country":46,"countryCode":18,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Institute of Endocrinology, Prague, a state-funded organization established by the Ministry of Health of the Czech Republic.",{"type":48,"coordinates":70},[50,51],{"lat":51,"lon":50},[73,77],{"name":74,"role":33,"phone":75,"phoneExt":18,"email":76},"Radka Taxova Braunerova, MD, Ph.D.","+420 224 905 111","rbraunerova@endo.cz",{"name":78,"role":33,"phone":75,"phoneExt":18,"email":79},"Pavla Kalouskova, MD","pkalouskova@endo.cz",{"facility":28,"status":43,"city":44,"state":18,"zip":81,"country":46,"countryCode":18,"cosmosGeoPoint":82,"geoPoint":84,"contacts":85},"14200",{"type":48,"coordinates":83},[50,51],{"lat":51,"lon":50},[86,87],{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},{"name":88,"role":33,"phone":38,"phoneExt":18,"email":89},"Michaela Ferenčakova","michaela.ferencakova@fgu.cas.cz",{"type":29,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Vit Zikan","Head of the Metabolic Bone Centre and Principal Investigator",[94,96],{"name":95,"class":6},"Czech Academy of Sciences",{"name":97,"class":98},"Ministry of Health, Czech Republic","OTHER_GOV","100649235","bone-marrow-adipose-tissue-in-relation-to-bone-and-energy-metabolism-in-obesity-and-type-2-diabetes-mellitus-100649235",false,"NCT07731438","Bone Marrow Adipose Tissue in Relation to Bone and Energy Metabolism in Obesity and Type 2 Diabetes Mellitus","Bone Marrow Adipose Tissue as a New Parameter in Relation to Bone and Energy Metabolism in Obesity and Type 2 Diabetes Mellitus","BOD-BMAT","Interventional Study: Effect of Caloric Restriction on BMAT\u002FBM-MSCs Phenotype\n\nInclusion Criteria:\n\n* Premenopausal women and age-eligible men assigned to either the obese intervention group or the lean control group\n* Obese intervention group:\n* Body mass index (BMI) of 30-42 kg\u002Fm²\n* Fasting plasma glucose less than 6.4 mmol\u002FL\n* Age 25-55 years\n* Lean control group:\n* BMI of 19-25 kg\u002Fm²\n* Fasting plasma glucose less than 6.4 mmol\u002FL\n* Age 25-50 years\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Secondary osteoporosis\n* History of severe neuropathic disease\n* Hyperparathyroidism\n* Hyperthyroidism\n* Immobilization\n* Alcoholism\n* Chronic gastrointestinal disease\n* Significant chronic renal impairment, including any of the following:\n* Chronic kidney disease\n* Serum creatinine greater than 110 µmol\u002FL\n* Estimated glomerular filtration rate (eGFR) less than 1 mL\u002Fs\u002F1.73 m²\n* Proteinuria\n* Diabetic nephropathy\n* Chronic hepatic impairment\n* Unstable cardiovascular disease\n* Uncontrolled hypertension\n* Current or recent use of any of the following medications:\n* Bisphosphonates\n* Estrogen\n* Denosumab\n* Gonadotropin-releasing hormone (GnRH) analogs\n* Glucocorticoids at a dose equivalent to at least 5 mg of prednisone daily for at least 1 month\n* Phenytoin\n* Thiazolidinediones\n* Insulin\n* Adrenal or anabolic steroids\n* Anticonvulsants\n* Anticoagulants\n* Pharmacological doses of vitamin D or vitamin A supplements\n* Contraindications to magnetic resonance imaging (MRI), including:\n* Pacemaker\n* Metallic implants incompatible with MRI\n* Claustrophobia",true,"ALL","21 Years","55 Years",{"count":112,"type":113},45,"ESTIMATED","INTERVENTIONAL",[116],"NA","This interventional study is part of a broader research project entitled \"Bone Marrow Adipose Tissue in Relation to Bone and Energy Metabolism in Obesity and Type 2 Diabetes Mellitus.\" The broader project includes both a cross-sectional study evaluating bone marrow adipose tissue and bone marrow mesenchymal stem cells in people with different metabolic and bone disorders and the present dietary intervention study.\n\nThe interventional study investigates whether caloric restriction changes bone marrow adipose tissue, bone health, whole-body metabolism, and the molecular and cellular characteristics of bone marrow mesenchymal stem cells in obese non-diabetic premenopausal women. A group of lean healthy premenopausal women will serve as a comparison group.\n\nParticipants in the intervention group will undergo an eight-week formula-based very-low-calorie diet using Cambridge Weight Plan products, providing approximately 2.5-3.35 MJ (600-800 kcal) per day, followed by a dietary weight-maintenance phase. Participants will receive nutritional counselling, and dietary adherence, body weight, physical activity, and clinical status will be monitored during scheduled study visits. Clinical and laboratory assessments will be conducted at baseline and after 2, 6, and 12 months.\n\nAssessments will include magnetic resonance imaging and proton magnetic resonance spectroscopy of the lumbar spine to measure the amount and lipid composition of vertebral bone marrow adipose tissue. Bone mineral density and body composition will be measured using dual-energy X-ray absorptiometry, with particular attention to bone mineral density at the total hip and femoral neck. Additional measurements will include body weight, waist and hip circumference, body composition, physical activity, and fasting blood tests evaluating bone turnover, glucose and lipid metabolism, inflammatory markers, hormones, and adipokines.\n\nBone marrow aspirates and abdominal subcutaneous adipose tissue biopsies will be obtained at baseline and after six months. Bone marrow-derived and adipose tissue-derived mesenchymal stem cells will be examined for changes in cellular composition, gene-expression profiles, metabolic activity, oxidative stress, differentiation capacity, and senescence-related characteristics. Single-cell RNA sequencing will be used to characterize specific bone marrow mesenchymal stem cell subpopulations.\n\nBone marrow plasma and other biological samples will also undergo metabolomic, lipidomic, and proteomic profiling using high-resolution mass spectrometry. These analyses will be used to identify extracellular molecules and molecular patterns associated with glucose and lipid metabolism, inflammation, cellular senescence, and the response to caloric restriction.\n\nThe study aims to determine whether diet-induced weight loss can improve the bone marrow microenvironment and modify vertebral bone marrow fat, bone parameters, and the metabolic and senescent phenotype of mesenchymal stem cells. The findings may help identify imaging, cellular, and molecular markers of obesity-related bone fragility.",[119],"Obesity",[121,119,22,122,123,124,125,126,127,128,129],"Bone marrow adipose tissue","Energy Metabolism","Magnetic Resonance imaging","Proton Magnetic Resonance Spectroscopy","Bone marrow mesenchymal stem cells","Bone metabolism","Cellular senescence","Single-cell RNA sequencing","Diet-induced weight loss","2026-07-22",{"date":132,"type":133},"2026-07-28","ACTUAL",{"date":135,"type":133},"2023-05-01",{"date":137,"type":113},"2027-01-21",{"name":5,"class":6},3]