Investigating the role of the glucagon-like peptide 1 system on foodcue-induced brain activation – a non-interventional longitudinalfunctional magnetic resonance imaging study

• Conditions: E66.9; Obesity, unspecified

• Registration Number: DRKS00033360
• Lead Sponsor: Zentralinstitut für Seelische Gesundheit, Klinik für Abhängiges Verhalten und Suchtmedizin, repräsentiert durch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Men and women between the ages of 18 and 60 who are receiving treatment with Wegovy® or Ozempic® (active ingredient: semaglutide) due to obesity/overweight

- Sufficient ability to communicate with the investigators and to answer questions in oral and written form

- Ability to give consent after receiving and understanding all the research-related information (Fully Informed Consent)

Exclusion Criteria

- Persons suffering from a mental illness (exceptions: Anxiety disorders, mild to moderate depression, nicotine consumption, alcohol use disorder)

- Contraindications for functional magnetic resonance imaging (e.g. metal implants and/or pacemakers that are not suitable for MRI)

- Use of psychotropics, painkillers containing opiates or drugs within the last ten days

- Withdrawal symptoms at the time of the examination (CIWA score > 3)

- Breath alcohol concentration > 0.0 per mille at the time of the examination

- Positive drug screening (amphetamines/ecstasy, opiates, cocaine, barbiturates, cannabis, benzodiazepines)

- Women who are pregnant or breastfeeding

- Current severe somatic comorbidities:
Liver cirrhosis or severely impaired renal function, severe heart failure,
pre-existing epilepsy

- Acute suicidal tendencies or acute danger to self or others

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is the neural brain activation in the Nucleus accumbens, measured using the blood oxygenated level dependent (BOLD) response, during the presentation of visual food and alcohol cues at different stages of the initiation and maintenance of Wegovy® or Ozempic® treatment (i.e. before treatment initiation, 4 weeks into treatment and 16 weeks into treatment).