Sleep, Obesity and Mental Disease - Biological Markers for the Evaluation of Circadian Rhythmicity

NCT05413486 | Unknown

• 1 other identifier: 21/61643
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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. People with mental illness have an increased risk of developing obesity. Both obesity and certain mental disorders (bipolar disorder and schizophrenia) are associated with circadian rhythm disorders. Clinically, this may manifest as reduced sleep quality, depressive symptoms and increased fatigue, but also deregulation of a wide range of bodily processes subject to the circadian rhythm. In circadian rhythm disorders, the pattern of how mRNA of specific 'clock genes' is expressed in the cell may be affected. These clock genes are associated with obesity, bipolar disorder and schizophrenia. Despite the clear indications of an interplay between mental illness, obesity and circadian rhythm disorders, the relationship between these illnesses are largely unexplored. Aim The aim of this study is to investigate circadian disturbances in people with and without obesity, as well as people with obesity and a comorbid diagnosis of either schizophrenia or bipolar disorder. Methods The study population will consist of:

1. 1.People with obesity and schizophrenia (N=22)
2. 2.People with obesity and bipolar disorder (N=22)
3. 3.People with obesity without psychiatric disease (N=22)
4. 4.People with BMI 18.5 - 25kg/m2 and no psychiatric disease (N=20)

Conditions

Bipolar Disorder; Schizophrenia; Obesity; Circadian Rhythm Disorders

Keywords

Obesity; Schizophrenia; Bipolar Disorder; Circadian disturbances; Hair follicles; Clock genes; Cortisol; Melatonin; Sleep; mRNA

Outcome Measures

Primary Outcomes (1)

• Daytime Circadian variation in clock gene mRNA expression

  Relative amount of different clock gene mRNA, compared to housekeeping gene

  for two full consecutive days participant will pluck hairs and place the hair root in a dissolution buffer. Participants will each collect 4 samples per day: immediately after waking, and every 6th preceding hour, including immediately before bed.

Secondary Outcomes (2)

• Daytime Circadian variation in saliva melatonin concentration

  for two full consecutive days participant will collect saliva samples. Participants will each collect ~6 samples per day: immediately after waking, 6 and 12 hours after waking and every 2 hours until bedtime, including a sample immediately before bed.

• Daytime Circadian variation in saliva cortisol concentration

  for two full consecutive days participant will collect saliva samples. Participants will each collect ~6 samples per day: immediately after waking, 6 and 12 hours after waking and every 2 hours until bedtime, including a sample immediately before bed.

Other Outcomes (3)

• Sleep amount and quality

  Participant will wear accelerometers for 8 consecutive days. The two self-sampling days and an additional 6 days.

• Continous glucose monitoring

  Participant will wear glucose monitors for 8 consecutive days. The two self-sampling days and an additional 6 days.

• Dietary intake and timing

  Participants will record dietary items for two consecutive days (the two self-sampling days)

Study Arms (4)

SCH, OB

People with obesity (BMI \> 30 kg/m2) and a medical diagnosis of schizophrenia spectrum disorder.

Other: Observational

BD, OB

People with obesity (BMI \> 30 kg/m2) and a medical diagnosis of bipolar spectrum disorder.

Other: Observational

Control, OB

Control group with obesity. People with obesity (BMI \> 30 kg/m2) without psychiatric disease or sleep disorders.

Other: Observational

Control, non-OB

Normal weight (BMI 18.5 - 25kg/m2) control group without psychiatric disease.

Other: Observational

Interventions

Observational OTHER

Exposure is defined by group affiliation i.e., Bipolar disorder vs. schizophrenia vs. no disease. Likewise with obesity vs. normal weight. Biological markers of daytime-circadian rhythmicity is compared across disease and weight groups.

BD, OB; Control, OB; Control, non-OB; SCH, OB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants may be recruited by two pathways: 1. Referral through psychiatric treatment units\* 2. Referral through the South Danish Obesity initiative (SDOI) * In addition to local treatment clinics this includes the following collabarative networks: OPT (Opsøgende Psykoseteam (english: outreach Psychosis team)), OPUS (Opsøgende Psykoseteam for Unge med Skizofreni (english: outreach Psychosis team for young adults with schizophrenia) and Psykinfo (a mental health information service in the Region of Southern Denmark). A third pathway is available for healthy controls: Posters are placed in libraries, groceries and educational facilities and by advertising in select local Facebook groups, especially targeting young (\>30 years) adults. While no formal exclussion criteria is presented regarding symptom severity. Health workers at psychiatric treatment units and SDOI will only refer participants with a high propability of completing the examination program.

You may qualify if:

• 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)

You may not qualify if:

• Participants taking oral supplements of melatonin are excluded if pausing is deemed inappropriate.

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead
• Steno Diabetes Center Odense: collaborator
• Region of Southern Denmark: collaborator
• Rigshospitalet, Denmark: collaborator
• University of Southern Denmark: collaborator
• Odense University Hospital: collaborator
• Odense Patient Data Explorative Network: collaborator

Study Sites (1)

Hospital South West Jutland

Esbjerg, 6700, Denmark

RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples tested for cortisol and melatonin content Hair follicle samples, tested for expression of specifically targeted clock genes.\* \*Hair follicles will be analyzed for gene expression using the PCR-based method real-time quantitative polymerase chain reaction (RT-qPCR). Investigators only obtain expression levels of genes targeted with specific commercially available primers. Therefore, NO information about the mRNA sequence or potential sequence variations in the selected set of genes will be investigated.

MeSH Terms

Conditions

Bipolar Disorder; Schizophrenia; Obesity; Chronobiology Disorders

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Claus B Juhl

  University Hospital South West Jutland, Department of Endocrinology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claus B Juhl, phD

CONTACT

60867272; Claus.Bogh.Juhl@rsyd.dk

Mikkel EI Kolind, MSc

CONTACT

31135292; mikkel.emil.iwanoff.kolind@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 10, 2022
• Study Start: April 4, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)