Medical comorbidities (and in particular Metabolic Syndrome, MetS) in people with bipolar disorder Mental and Behavioural Disorders
Conditions
Interventions
BIPCOM uses a multifaceted and integrated approach to study Metabolic Syndrome (MetS), and other medical comorbidities (MC), in Bipolar Disorder (BD). There are several primary studies assessing one o
Sponsors
ERA PERMED
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Primary diagnosis of BD I or BD II 2. At least one contact with the mental health service in the last year 3. Age 18-65 years 4. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Plan to relocate in the subsequent year 2. Severe psychiatric comorbidities (schizophrenia spectrum disorders) 3. Severe cognitive impairment 4. Severe substance/alcohol misuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At baseline (T0) and one year (T1): 1. Assessment for health and disability measured using World Health Organization Disability Assessment Schedule 2.0, 12-items, self-report version (WHODAS 2.0); 2. Assessment of real-life functioning measured using Specific Levels Of Functioning (SLOF); 3. Index od comorbidities of patients measured using Elixhauser Comorbidity Index (ECI); 4. Life events measured using Life Events and Difficulties Schedule; 5. Subjective health status measured using EQ5D Health questionnaire; 6. Assessment of sleep quality and disturbances measured using Pittsburgh Sleep Quality Index (PSQI); 7. Subjective health status measured with Short Form Health Survey (SF-36); 8. Evaluation of the disorder course with the retrospective and prospective (during the 1-year follow-up) measured using The Life Story Interview 9. Evaluation of: history of alcohol or drug abuse using a standardized tool; lifestyle habits, such as PA using accelerometers; dietary habits using the Short Form of the Food Frequency Questionnaire (SHFFQ) as well as the APPetite-mobile-app. 10. MetS diagnostic criteria: 10.1. Waist circumference based on population or country-specific definitions 10.2. Elevated triglycerides (or current drug treatment for high triglycerides) >150 mg/dL (1.7 mmol/L) 10.3. Reduced HDL-cholesterol 130 and/or diastolic >85 mm Hg 10.5. Elevated fasting glucose (or ongoing drug treatment) >100 mg/dL (5.5 mmol/L) | — |
Secondary
| Measure | Time frame |
|---|---|
| At baseline (T0) and one year (T1): 1. Fatty liver index, assessed after FLI, included in the table on biomarkers. 2. Liver fibrosis, assessed after FIB-4, included in the table on biomarkers. 3. Physical Activity assessment and comparison of two groups (MetS+/MetS- patients): total PA, intensity specific PA, sedentary time and circadian rhythms in the two groups and associations between PA and sedentary activity with selected clinical markers, through accelerometer. | — |
Countries
France, Germany, Italy, Norway, Spain, Sweden
Outcome results
None listed