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Bone Marrow Adipose Tissue in Relation to Bone and Energy Metabolism in Obesity and Type 2 Diabetes Mellitus

RecruitingNAAges 21 Years - 55 YearsAllGeneral University Hospital, Prague
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In plain words

What the trial is, and whether it could suit you

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. The 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. Participants in the intervention group will undergo an eight-week formula-based very-low-calorie diet using Cambridge Weight Plan produc

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Interventional Study: Effect of Caloric Restriction on BMAT/BM-MSCs Phenotype Inclusion Criteria: * Premenopausal women and age-eligible men assigned to either the obese intervention group or the lean control group * Obese intervention group: * Body mass index (BMI) of 30-42 kg/m² * Fasting plasma glucose less than 6.4 mmol/L * Age 25-55 years * Lean control group: * BMI of 19-25 kg/m² * Fasting plasma glucose less than 6.4 mmol/L * Age 25-50 years Exclusion Criteria: * Diabetes mellitus * Secondary osteoporosis * History of severe neuropathic disease * Hyperparathyroidism * Hyperthyroidism * Immobilization * Alcoholism * Chronic gastrointestinal disease * Significant chronic renal impairment, including any of the following: * Chronic kidney disease * Serum creatinine greater than 110 µmol/L * Estimated glomerular filtration rate (eGFR) less than 1 mL/s/1.73 m² * Proteinuria * Diabetic nephropathy * Chronic hepatic impairment * Unstable cardiovascular disease * Uncontrolled hypertension * Current or recent use of any of the following medications: * Bisphosphonates * Estrogen * Denosumab * Gonadotropin-releasing hormone (GnRH) analogs * Glucocorticoids at a dose equivalent to at least 5 mg of prednisone daily for at least 1 month * Phenytoin * Thiazolidinediones * Insulin * Adrenal or anabolic steroids * Anticonvulsants * Anticoagulants * Pharmacological doses of vitamin D or vitamin A supplements * Contraindications to magnetic resonance imaging (MRI), including: * Pacemaker * Metallic implants incompatible with MRI * Claustrophobia
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What it tests

  • Caloric Restriction
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Where

3 sites
General University Hospital in Prague
Prague, Czechia
Institute of Endocrinology, Prague, a state-funded organization established by the Ministry of Health of the Czech Republic.
Prague, Czechia
Institute of Physiology of the Czech Academy of Sciences
Prague, Czechia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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