Status:
COMPLETED
How Altered Gut-Brain-Axis Influences Food Choices: Part 1
Lead Sponsor:
Lia Bally
Collaborating Sponsors:
ETH Zurich
Conditions:
Obesity
Food Preferences
Eligibility:
All Genders
18+ years
Brief Summary
Obesity is currently one of the most substantial health burdens. Due to the production of marked and sustained weight loss, bariatric surgery is an increasingly used therapeutic modality to combat obe...
Detailed Description
The overall aim of this project is to elucidate the neurobehavioural underpinnings of food behaviour among obese adults and how food behavior is altered by different obesity treatments.To this end, th...
Eligibility Criteria
Inclusion
- Inclusion criteria (all participants):
- Female and male subjects aged 18 years or older
- Proficient German language skills (including written)
- Inclusion criteria for Group 1 (pilot protocol):
- Class II-III obesity (BMI≥35kg/m2)
- Planned for bariatric surgery (Roux-en-Y gastric bypass)
- Inclusion criteria for Group 1 (refined protocol):
- BMI≥30kg/m2 or BMI≥28kg/m2 with adiposity-related comorbidities (prediabetes, type 2 diabetes mellitus, hypertension, dyslipidemia)
- Referred for obesity treatment (surgical or non-surgical)
- Inclusion criteria for Group 2 (pilot and refined protocols):
- Normal body weight (BMI 18.5-24.9kg/m2)
- Absence of evidence of any active or chronic disease as judged by the Clinical Investigator
- Exclusion criteria:
- Incapacity to give informed consent
- Previous or current neurological or severe psychiatric illness
- Current or planned pregnancy or breastfeeding
- Claustrophobia
- MRI-contraindications (pacemaker/defibrillator, neurostimulator, drug pump, cochlear implant, heart valve/vascular clips, shunt valve)
- Pilot protocol only: Diabetes according to WHO (World Health Organization ) definition (Fasting plasma glucose ≥7.0mmol/l, random plasma glucose ≥11.1mmol/l, HbA1c ≥6.5%)
Exclusion
Key Trial Info
Start Date :
April 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 5 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04813003
Start Date
April 12 2021
End Date
September 5 2022
Last Update
September 23 2022
Active Locations (1)
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1
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Bern, Switzerland, 3010