ight therapy for depression and diabetes

Recruiting

Conditions: major depression
type 2 diabetes mellitus

Registration Number: NL-OMON25152

Lead Sponsor: VU University Medical Center, Department of Psychiatry/ GGZ inGeest

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 74

Inclusion Criteria

(1) male and female subjects 18 years or older; (2) having type 2 diabetes mellitus as judged by an expert panel based on HbA1c, diabetes medical history, use of glucose-lowering medication, and when deemed necessary additional tests (e.g. antibodies); and (3) having a major depressive episode according to DSM-IV criteria

Exclusion Criteria

1) a recent history of, or current, light therapy; (2) shift worker; (3) a recent change in antidepressant or blood-glucose lowering medication or therapy (e.g. psychotherapy); (4) use of oral glucocorticoids, melatonin, or cytostatics; (5) pregnancy; (6) psychosis, mania, (probable) dementia, severe drug or alcohol abuse, delirium, and severe acute suicidality; (7) a history of light-induced migraine or epilepsy, or severe side effects to light therapy in the past; (8) visual acuity <60%, diabetic retinopathy EURODIAB grades 3, 4 or 5 (severe non-proliferative or preproliferative retinopathy, photocoagulated retinopathy, proliferative retinopathy), senile macula degeneration; (9) a(nother) medical condition or recent medical event that potentially compromises the effects or safety of light therapy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depression symptoms (Inventory of Depressive Symptoms (IDS)); insulin sensitivity (hyperinsulinaemic euglycaemic clamp).

Secondary Outcome Measures

Name	Time	Method
Psychometrical secondary outcome measures will include depression remission (IDS score of 13 or less); anxiety symptoms (Beck Anxiety Inventory); diabetes distress (Problem Areas In Diabetes questionnaire); and quality of life (EQ-5D) and disability (Sheehan Disability Scale). Endocrine secondary outcome measures will include HbA1c, fasting plasma glucose, insulin dosage (in insulin dependant participants) as reported in the trial diary, and number of hypoglycaemic events as reported in the trial diary. Mediating factors that reflect circadian rythmicity will include diurnal HPA-axis activity, objective accelerometer measures of sleep duration, and subjective measures of sleep duration and quality (questionnaires). Other potential mediating factors include autonomic nervous system function; body weight, body mass index, and body composition (percentage of fat and lean muscle, waist-hip ratio) as measured by bioelectrical impedance analysis; and physical activity as measured using a wrist worn accelerometer.