Status:
RECRUITING
Sleep, Obesity and Mental Disease - Biological Markers for the Evaluation of Circadian Rhythmicity
Lead Sponsor:
Esbjerg Hospital - University Hospital of Southern Denmark
Collaborating Sponsors:
Steno Diabetes Center Odense
Region of Southern Denmark
Conditions:
Bipolar Disorder
Schizophrenia
Eligibility:
All Genders
18-60 years
Brief Summary
Introduction 16.8% of the Danish adult population are obese (Body Mass Index\> 30 kg / m2). Obesity increases the risk of lifestyle diseases such as type-2 diabetes and non-alcoholic fatty liver. Peo...
Detailed Description
Background Obesity (30 ≥ kg/m2) is a major global health challenge. Worldwide obesity has nearly tripled since 1975 (WHO, 2021) and is projected to continue to rise throughout western society (OECD, ...
Eligibility Criteria
Inclusion
- Fulfilling the criteria for one of the four study groups:
- People with BMI \> 30 kg/m2 and schizophrenia spectrum disorder (N=22)
- People with BMI \> 30 kg/m2 and bipolar disorder spectrum disorder (N=22)
- People with BMI \> 30 kg/m2 without psychiatric disease or sleep disorders (N=22)
- People with BMI 18.5 - 25kg/m2 and no psychiatric disease or sleep disorders (N=20)
Exclusion
- Participants taking oral supplements of melatonin are excluded if pausing is deemed inappropriate.
Key Trial Info
Start Date :
April 4 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2024
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT05413486
Start Date
April 4 2022
End Date
July 31 2024
Last Update
January 5 2024
Active Locations (1)
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1
Hospital South West Jutland
Esbjerg, Denmark, 6700