No registrations found.
ID
Source
Health condition
major depression; type 2 diabetes mellitus
Sponsors and support
Intervention
Outcome measures
Primary outcome
Depression symptoms (Inventory of Depressive Symptoms (IDS)); insulin sensitivity (hyperinsulinaemic euglycaemic clamp).
Secondary outcome
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.
Study design
Measures will be normally performed at three time points: just before the start of light therapy, after completion of four weeks of light therapy, and after four weeks follow-up. Several measures will be evaluated continuously during the intervention period.
Intervention
The intervention will consist of light therapy for four weeks 30 minutes every morning at home with bright white-yellowish light or dim green light.
M.A. Bremmer,
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4440196
ma.bremmer@vumc.nl
M.A. Bremmer,
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4440196
ma.bremmer@vumc.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4802 |
| NTR-old | NTR4942 |
| CCMO | NL45295.029.13 |
| OMON | NL-OMON44883 |