Exploring the links between sleep, obesity, and mental health
Circadian Disturbances in People With Mental Disease
This study looks at how sleep patterns and certain genes might connect obesity with bipolar disorder and schizophrenia in people with different body weights.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Esbjerg Hospital - University Hospital of Southern Denmark Academic / other |
| Locations | 1 site (Esbjerg) |
| Trial ID | NCT05413486 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between obesity, bipolar disorder, schizophrenia, and circadian rhythm disorders. It aims to analyze how specific 'clock genes' are expressed in individuals with these conditions, focusing on those with a Body Mass Index (BMI) over 30 and those with a normal BMI. By examining biological markers related to circadian rhythms, the study seeks to uncover the interplay between these health issues. Participants will be grouped based on their BMI and mental health status to facilitate a comprehensive analysis.
Who should consider this trial
Good fit: Ideal candidates include individuals with a BMI over 30 who have schizophrenia or bipolar disorder, as well as those without psychiatric conditions but with obesity.
Not a fit: Patients with a BMI below 18.5 or those taking melatonin supplements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of obesity and mental health disorders through circadian rhythm interventions.
How similar studies have performed: While the interplay between these conditions is recognized, this specific approach to studying biological markers in relation to circadian rhythms is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: * Participants taking oral supplements of melatonin are excluded if pausing is deemed inappropriate.
Where this trial is running
Esbjerg
- Hospital South West Jutland — Esbjerg, Denmark (Recruiting)
Study contacts
- Principal investigator: Claus B Juhl — University Hospital South West Jutland, Department of Endocrinology
- Study coordinator: Claus B Juhl, phD
- Email: Claus.Bogh.Juhl@rsyd.dk
- Phone: 60867272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.