The main objective is to unravel the consequences of obesity treatment on women*s longer-term health, with a primary focus on musculoskeletal health (muscle mass and bone mineral density). Transgenerational consequences of obesity treatment on…
ID
Source
Brief title
Condition
- Malabsorption conditions
- Vitamin related disorders
- Musculoskeletal and connective tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main parameters are changes in nutrient intake and status as well as muscle
mass and bone mineral density. Muscle strength, muscle fat infiltration and
bone marrow adipose tissue are main outcomes of the subgroup. Main endpoints of
the birth cohort are foetal growth and child development.
Secondary outcome
Secondary parameters are lifestyle factors and parameters of the endocrine and
reproductive systems (i.e., menstrual complaints, thyroid function and hormonal
changes).
Background summary
Although obesity treatment is effective in reducing long-term bodyweight and
obesity-related comorbidities for the majority of patients with severe obesity,
it also negatively impacts nutritional status (vitamins, minerals, but also
proteins), which may negatively impact health, for example disproportional loss
of muscle mass and bone mineral density, particularly in menopausal women.
Furthermore, impaired nutritional status during subsequent pregnancy may
potentially be detrimental for foetal growth and child development of the
estimated 50% of women who become pregnant after obesity treatment. The
transgenerational effects of obesity and obesity treatment induced maternal
nutrient deficiencies on foetal growth and child development remain unclear.
Study objective
The main objective is to unravel the consequences of obesity treatment on
women*s longer-term health, with a primary focus on musculoskeletal health
(muscle mass and bone mineral density). Transgenerational consequences of
obesity treatment on maternal health, foetal growth and child development will
be studied within the birth cohort.
Study design
Prospective observational cohort study.
Study burden and risks
Participants will be asked to complete questionnaires, to wear an accelerometer
during one week, to have a BIA measurement taken, to perform a handgrip
strength and chair stand test, to donate additional blood as part of regular
venapuncture, and to collect urine and faeces samples.
A subgroup of participants will be asked to undergo a DEXA, MRI and legpress
measurement.
Participants who become pregnant during the course of the study will be asked
to collect a small amount of human milk. Foetal growth and child development
will be monitored as part of usual care and collected via the mother. A
subgroup of the pregnant women will be asked to have a qualitative ultrasound.
Filling out questionnaires brings no harm.
Collecting additional blood via venapuncture as part of regular care will not
cause any additional bruises.
No risks have been reported for having a DEXA, MRI or quantitative ultrasound.
Stippeneng 4
Wageningen 6708WE
NL
Stippeneng 4
Wageningen 6708WE
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for the cohort:
- Female at birth
- Aged 18-55 years of age
- Living with obesity (BMI => 30kg/m^2)
- Approved for obesity treatment in one of the participating hospitals.
- Undergoing bariatric surgery (RYGB OAGB, or SG)
- Receiving obesity medication (any type) under medical supervision with
BMI => 30kg/m^2)
- For those undergoing MRI, DEXA and quantitative ultrasound scan: Willing to
be informed about incidental findings of pathology and approving of reporting
this to their general physician.
Additional criteria for the (integrated) birth cohort:
- Being pregnant, or having pregnancy wish
- Age 18-45 years of age
- Having received prior obesity treatment (either surgical (RYGB, SG) or
pharmacological, at least 4 months)
Exclusion criteria
Exclusion criteria for the cohort:
- Male sex at birth
- Aged <18 or >55 years of age
- BMI <30 kg/m^2
- Not able to read and/or write Dutch
- Undergoing a revisional or secondary bariatric procedure (excluding previous
gastric banding)
- Malnutrition due to other chronic condition, specifically malignancy,
substance abuse
- (mental) condition that makes it impossible to fill out a questionnaire
correctly.
Additional criteria for the (integrated) birth cohort:
- Aged <18 or >45 years of age
- >25 weeks of gestation
- Multiple pregnancy
- Reversal of the bariatric procedure
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86647.091.24 |