Weight loss and bone marrow fat in obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines the effects of caloric restriction on bone marrow adipose tissue, bone health, and whole-body metabolism in obese non-diabetic premenopausal women. Participants follow a formula-based very-low-calorie diet for eight weeks, then transition to a weight-maintenance plan. A lean healthy premenopausal group serves as a reference. The study also looks at how restrictions influence the cellular and molecular features of bone marrow mesenchymal stem cells. The broader project includes a cross-sectional arm, not described here, focusing on BMAT and BM-MSCs in varied metabolic and skeletal conditions.

Why it matters

Who can join: the full rules

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

Where it's running

• General University Hospital in Prague
  Prague, Czechia Recruiting
• Institute of Endocrinology, Prague, a state-funded organization established by the Ministry of Health of the Czech Republic.
  Prague, Czechia Recruiting
• Institute of Physiology of the Czech Academy of Sciences
  Prague, Czechia Recruiting

Study contacts

• Principal investigator: Michaela Tencerova, MSc, PhD — Institute of Physiology of the Czech Academy of Sciences
• Study coordinator: Vit Zikan, MD, Ph.D.
• Email: vit.zikan@vfn.cz
• Phone: +420731670425

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.