The objective of the study is to determine hypothalamic function in response to oral glucose ingestion in subjects with obesity before and after the start of a combined lifestyle intervention (CLI).
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Hypothalamic activity as measured by BOLD signal intensity of the
hypothalamus after ingestion of solution (75 gram in 300ml) in patients with
obesity before CLI (baseline)
- Hypothalamic activity as measured by BOLD signal intensity of the
hypothalamus after ingestion of solution (75 gram in 300ml) in patients with
obesity after CLI (in-tervention effect)
- Differences in BOLD signal intensity before and after a CLI
- Comparison in BOLD signal intensity between patients with obesity, healthy
con-trols (data previously collected), and patients with diabetes mellitus type
2 ( previ-ously collected).
Secondary outcome
- Resting state whole brain fMRI outcome measures:
- Voxel-based connectivity as measured by Eigen vector centrality
mapping of resting FMRI data
- Network connectivity as measured by network Z-scores of functional
connec-tivity of resting FMRI data
- Associations between MRI data and questionnaires, anthropometrics,
biochemical and metabolic parameters, immunological parameters and endocrine
parameters collected at the Erasmus MC.
Background summary
In obesity the homeostatic energy balance is disrupted, which leads to an over
storage of energy in the form of excess bodyweight. The brain plays a very
important role in regulating homeostasis and energy balance. Various earlier
studies have shown an altered function and response of the brains of persons
with obesity. We hypothesize that participants with obesity will demonstrate an
attenuated hypothalamic response to glucose ingestion and that this response
could be improved after an improved diet and weight loss.
Study objective
The objective of the study is to determine hypothalamic function in response to
oral glucose ingestion in subjects with obesity before and after the start of a
combined lifestyle intervention (CLI).
Study design
Prospective cohort study with baseline measurements and measurements after
intervention.
Study burden and risks
The study will consist of two visits to the LUMC (10 weeks between visits). For
each visit participants will undergo one MRI scan, the duration of this visit
will be 1.5 -2 hours excluding travel time (one hour for the MRI scan plus
instructions and preparations).
The potential risks are limited. The risks of MRI are minimal (risk of everyday
life), because there are no consequences to the health of the participant.
Potential risks from the MRI study include movement of paramagnetic objects in
the body. Furthermore, some subjects may feel claustrophobic in the restricted
space of the MR scanner.
Albinusdreef 2
Leiden 2300RC
NL
Albinusdreef 2
Leiden 2300RC
NL
Listed location countries
Age
Inclusion criteria
Participants with a Body Mass Index (BMI) > 30 kg/m2 with obesity related
comorbidities. Allowed comorbidities are defined as follows:
- Insulin resistance (as defined by the HOMA index based on fasted
insulin/glucose)
- Dyslipidaemia
- Hypertension
- Arthrosis
- Sleep apnoea
- Fatty liver disease
- Polycystic Ovary Syndrome (PCOS)
Exclusion criteria
- Does not speak Dutch
- Cognitive impairment (IQ<80)
- Physical impairment that impairs movement therapy.
- Other underlying treatable causes of obesity
- Lack of motivation
- Behavioural problems that impair group therapy.
- Psychopathologies pathology that require other treatment
- Current desire to have children
- Diabetes mellitus type 2
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL68911.058.19 |