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Weight loss surgery and changes in bone marrow fat and bone mass.


- candidate number21636
- NTR NumberNTR5056
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-feb-2015
- Secondary IDsNL51696.018.14 
- Public TitleWeight loss surgery and changes in bone marrow fat and bone mass.
- Scientific TitleBariatric surgery, bone barrow fat dan bone mineral density.
- ACRONYMFatBar
- hypothesisEnergy restriction by bariatric surgery in obese women increases bone marrow fat and decreases bone mass.
- Healt Condition(s) or Problem(s) studiedObesity, Osteoporosis, Surgery induced weight loss
- Inclusion criteria* Female sex
* Age: 18-55 years50 years and older
* Postmenopausal
* Scheduled for Roux-en-Y gastric bypass
* Able to fit on MRI table
- Exclusion criteria* Contraindications to MRI scanning
* Use of bone-modifying or adipose tissue-modifying drugs
* Bone / bone marrow diseases
* Diseases or medication known to have an effect on bone marrow fat
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2015
- planned closingdate1-mrt-2016
- Target number of participants20
- InterventionsRoux-en-Y gastric bypass
- Primary outcome* Vertebral bone marrow fat fraction measured by QSCI
* Vertebral bone mineral density measured by QCT
- Secondary outcomeBone turnover markers (CTx, P1NP, osteocalcin), 25-hydroxy vitamin D, parathyroid hormone, calcium, albumin, phosphate, alkaline phosphatase, creatinin, complete blood count (CBC), reticulocytes, leptin, adiponectin
- Timepoints* 3 months and 2 weeks pre-operative
* 3 and 12 months post-operative
- Trial web siteNA
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. P.H.L.T. Bisschop
- CONTACT for SCIENTIFIC QUERIESDr. P.H.L.T. Bisschop
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summaryBone marrow fat and bone mineral density are inversely correlated. Greater bone marrow fat is also associated with fractures. Bone marrow fat is regulated differently from visceral and subcutaneous fat. In rodents, caloric restriction results in high bone marrow fat. However, little studies have been published that examined the effects of weight loss on bone marrow fat in humans.
- Main changes (audit trail)
- RECORD2-feb-2015 - 18-apr-2015


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