The objective of the study is to investigate vertebral bone marrow fat fraction and bone mineral density during surgery induced weight loss.
ID
Source
Brief title
Condition
- Bone, calcium, magnesium and phosphorus metabolism disorders
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Vertebral bone marrow fat fraction measured by quantitative chemical shift
imaging (QCSI)
* Vertebral volumetric bone mineral density measured by quantitative computed
tomography (QCT)
Secondary outcome
* Bone turnover markers (CTx, P1NP, osteocalcin), vitamin D, PTH, calcium,
leptine, adiponectine
Background summary
The prevalence of obesity worldwide has increased significantly and recent data
show that obesity and poor bone health coexist. While treatment of obesity is
associated with improved health outcome, it induces detrimental effects on bone
health. These data are difficult to interpret due to difficulties in the
accuracy of bone mineral density measurements in morbid obesity and during
weight loss.
One of the potential mechanisms by which obesity might negatively affect bone
is via bone marrow fat. Bone marrow fat is an unique component of the bone
marrow cavity that is functionally distinct from and not subject to the same
regulation as subcutaneous- and visceral fat depots. To date, no study has
investigated bone marrow fat changes in patients following bariatric surgery.
Therefore we will investigate changes in bone mineral density and bone marrow
fat following weight loss in subjects who undergo bariatric surgery.
Study objective
The objective of the study is to investigate vertebral bone marrow fat fraction
and bone mineral density during surgery induced weight loss.
Study design
Longitudinal study
Study burden and risks
Subjects will visit our research unit four times in 15 months: two baseline
measurements (3 months and 2 weeks prior to surgery), and two post-operative
measurements (3 and 12 months post-operatively). Each visit a venous blood
sample will be drawn and bone mineral density and vertebral bone marrow fat
fraction will be measured by QCT and QCSI, respectively. As the dose equivalent
per QCT scan amounts to 1.2 mSv, the total dose equivalent of the participants
will be 4.8 mSv for the total study period (IRCP category IIb). The QCSI
procedure is a non-invasive, non-ionizing imaging technique without contrast
administration. This procedure will take approximately 30 minutes per
procedure. Risks associated with venous blood sampling are negligible. The
total volume of blood samples from the entire protocol over 15 months will not
exceed 200 mL. The subjects included in this study will not directly benefit
from the results. However, the participation of the subjects will potentially
benefit other people undergoing bariatric surgery in the future; therefore
altruistic motives could represent a personal benefit.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
* Female sex
* Age: 50 years and older
* Postmenopausal
* Scheduled for Roux-en-Y gastric bypass (RYGB)
* Able to fit on MRI table
Exclusion criteria
* Contraindications to MRI scanning as determined by a standard checklist
* 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL51696.018.14 |
| OMON | NL-OMON23764 |