Functional magnetic resonance imaging of human hypothalamic responses to oral glucose ingestion in subjects with obesity before and after lifestyle intervention.

Completed

Conditions: Obesity
Over weight
10021112
10003018

Registration Number: NL-OMON49389

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Hypothalamic activity as measured by BOLD signal intensity of the<br /><br>hypothalamus after ingestion of solution (75 gram in 300ml) in patients with<br /><br>obesity before CLI (baseline)<br /><br>- Hypothalamic activity as measured by BOLD signal intensity of the<br /><br>hypothalamus after ingestion of solution (75 gram in 300ml) in patients with<br /><br>obesity after CLI (in-tervention effect)<br /><br>- Differences in BOLD signal intensity before and after a CLI<br /><br>- Comparison in BOLD signal intensity between patients with obesity, healthy<br /><br>con-trols (data previously collected), and patients with diabetes mellitus type<br /><br>2 ( previ-ously collected). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Resting state whole brain fMRI outcome measures:<br /><br>- Voxel-based connectivity as measured by Eigen vector centrality<br /><br>mapping of resting FMRI data<br /><br>- Network connectivity as measured by network Z-scores of functional<br /><br>connec-tivity of resting FMRI data<br /><br>- Associations between MRI data and questionnaires, anthropometrics,<br /><br>biochemical and metabolic parameters, immunological parameters and endocrine<br /><br>parameters collected at the Erasmus MC.</p><br>