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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49389

Enrollment

Registered

2019-08-22

Start date

2019-10-03

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Over weight

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Does not speak Dutch - Cognitive impairment (IQ

Design outcomes

Primary

Measure	Time frame
- 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).	—

Measure

Time frame

- 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).

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Secondary

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

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Countries

Netherlands

Outcome results